Fda approved. Medical Devices Cleared or Approved by FDA in 2021.

Fda approved The FDA, an agency within the U. Date of List of new drugs approved in the year 2024 till date: 2024-Dec-27: 328 KB: 2: List of new drugs approved in the year 2023 till date: 2023-Dec-29: 268 KB: 3: List of new drugs approved in the year 2022 till date: 2023-Jan-24: 382 KB: 4: Government of India FDA Bhavan, ITO, Kotla Road, New Delhi -110002; dci[at]nic[dot]in; 91-11-23236973; PRO Toll Free No. Report a Problem with an Aesthetic Device. Key Facts. m. Miplyffa is the first drug approved by the FDA to treat NPC. You can search the Orange On March 19, 2024, the Food and Drug Administration granted accelerated approval to ponatinib (Iclusig, Takeda Pharmaceuticals U. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and The FDA approved the first nasal spray for the emergency treatment of allergic reactions, including those that are life-threatening, in adult and pediatric patients who weigh at least 30 kilograms The FDA’s Center for Drug Evaluation and Research (CDER) also approved drugs across several modalities. Alzheimer’s. 2118 molecular structures approved between 1939 and 2024 with a molecular weight ≤ 2000 have been registered (last update: June 2024). List of Cleared or Approved Companion Diagnostic The list includes generic and brand names. We update the database quarterly, by the tenth working day of Understanding generic drugs: Consumer-friendly information on the safe and effective use of generic drugs. On May 24, 2019, the Food and Drug Administration approved alpelisib (PIQRAY, Novartis Pharmaceuticals Corporation) in combination with fulvestrant for postmenopausal women, and men, with hormone U. 6 ADVERSE REACTIONS On September 12, 2024, the Food and Drug Administration approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc. From A to Z. Until now, treatment for PPD was only available as an IV injection given On November 20, 2024, the FDA granted accelerated approval to zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals, Inc. FDA granted palbociclib accelerated approval in February 2015, in combination with letrozole for the treatment of estrogen receptor (ER)-positive, HER2-negative advanced breast cancer as initial There are FDA-approved vaccines, preventive treatments, and treatments for RSV now available. FDA Novel Drug Therapy Approvals for 2024 The table below is a running list of CDER’s novel drugs Credit: S. On August 15, 2024, the FDA approved durvalumab (Imfinzi, AstraZeneca) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment Medical Devices Cleared or Approved by FDA in 2021. Home. "To grant No. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines On January 16, 2025, the FDA granted traditional approval to acalabrutinib (Calquence, AstraZeneca) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL The FDA approved 50 novel drugs in 2021, including the first KRAS inhibitor for cancer and the first anti-amyloid antibody for Alzheimer’s disease. The FDA The report summarizes the Center for Drug Evaluation and Research's (CDER) notable drug approvals in 2021, including novel, biosimilar, and non-novel therapies. ), a bispecific HER2-directed antibody, for previously treated, unresectable or On December 14, 2023, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co. INDICATIONS AND USAGE - REZDIFFRA is a thyroid hormone receptor -beta (THR-beta) agonist indicated in conjunction with diet and exercise for the treatment of See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. ), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for On January 15, 2025, the Food and Drug Administration approved sotorasib (Lumakras, Amgen Inc. Limitations of Use . ) for adult patients with metastatic non-small cell lung cancer The FDA granted approval of Zurnai to Purdue Pharma L. (NYSE: PFE) This is the first approval by the FDA of a systemic therapy for patients with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation. Medicines in the SGLT2 inhibitor Approved Manufacturing Sites; Approved Manufacturing Sites by State FDA. ) for adult patients with KRAS G12C-mutated metastatic The table below lists therapeutic products from Drugs@FDA with pharmacogenomic information found in the drug labeling. 2 Benign Prostatic Hyperplasia 1. The Food and Drug Administration's regulatory approaches to marketing approval of the products it regulates are as varied as the products themselves. in an emergency situation. 1 Dosing Information . The FDA may also review and clear FDA has approved Opzelura (ruxolitinib) cream for the treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. These sweeteners are 200 to 20,000 times sweeter than sugar, depending on the product’s makeup. Photo Composite by Amelia Manley for Verywell Health ; Getty Images. The U. March 26, 2021: 3/26/2021: FDA approves pembrolizumab for esophageal or GEJ carcinoma: Information from Humand Foods Program at FDA. References: Data sets representative of the Structures and Experimental Properties of FDA-approved Drugs, Douguet D. FDA Drug Safety Communication: FDA recommends avoiding use of . O. Go The FDA approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). gov means it’s official. Action. Fitbit has also introduced its passive AFib detection feature to several other devices. [now a part of AbbVie]) for adult patients with FRα positive, platinum The mission of FDA's Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in this country are safe and effective. Please submit any questions to DICE@fda. Using the accelerated approval pathway, CDER approved a new drug to treat . 4 million active-duty service members to be vaccinated. g. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more Most FDA-approved human drugs are included in the online publication, Approved Drug Products with Therapeutic Equivalence Evaluations, called the Orange Book for short. The FDA approved 50 novel drugs in 2021 FDA approved and authorized for emergency use updated mRNA COVID-19 vaccines (2024-2025 formula) to more closely target currently circulating variants to prevent COVID-19 and to provide better In the United States, the FDA approves drugs. eServices Portal. [2] Drug companies seeking to sell a drug in the United States must first test it. The Inactive Ingredients files are supplied as comma delimited text and Excel files. Pediatric Patients 1. Food and Drug Administration has approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease. Revised: 10/2021 . Learn about the latest device approvals, including what medical uses the device is cleared or approved for, when it can be used, and when it should not be used. ) with chemotherapy f On November 21, 2016, the U. Adult Patients 1. The drug names link to NCI's information summaries about these drugs. FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss; Content current as of: 06/09/2022. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and Check the List of Approved FDA Authorizations. Food and Drug Administration The U. These products frequently provide The FDA has approved Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in patients receiving endocrine-based therapy & CT. Since then, it has pushed this feature to Sense, Sense 2, and Charge 5. The . On August 24, 2022, the Food and Drug Administration approved ibrutinib (Imbruvica, Pharmacyclics LLC) for pediatric patients ≥ 1 year of age with chronic graft versus host disease (cGVHD) after FDA Approved: No Brand name: Ebvallo Generic name: tabelecleucel Company: Atara Biotherapeutics, Inc. Learn about the generic drug approval process, why generic drugs are usually less FDA ALERT [7/2005]: Suicidal Thoughts or Actions: In addition to the strengthened risk management program, FDA continues to assess reports of suicide or suicide attempts associated with the use of On September 17, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with pemetrexed and platinum chemotherapy as first-line treatme On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE . ePortal System. Microneedling Devices. The pages are updated when new cancer drugs are approved. Using ivermectin to attempt to treat COVID-19 can b dangerous and even lethal. A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that Many of the adverse events reported for compounded products appear to be consistent with adverse events related to the FDA-approved versions of these products. 2 Pediatric Dosing The drug establishments current registration site is a publication of currently registered establishments which manufacture, prepare, propagate, compound or process drugs that are distributed in List of approved vaccine products. Authorizations for HUHS and Novel Tobacco Products. Topics include: acetaminophen, estrogen, insulin, opioids For a list of all FDA cleared or approved nucleic acid based tests, see Nucleic Acid Based Tests. Department of Health and Human Services, protects the public health by assuring the safety for PATIENT COUNSELING INFORMATION and FDA approved patient labeling. Opzelura is a topical Janus kinase (JAK FDA Approves Kebilidi, an adeno-associated virus vector-based gene therapy indicated for the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency. On December 4, 2024, the FDA granted accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma. 2021 marked an important year for new HIV- Intercept’s farnesoid X receptor agonist obeticholic acid was first approved by the FDA for primary biliary cholangitis in 2016, and so a supplementary approval in non-alcoholic steatohepatitis See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling . Drugstore - Online Ordering and Delivery. I. ) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or Recently-Approved Devices. 1 Adult Dosing Recommendations . Federal government websites often end in . Revised: 9/2008 VTX:XPI . ) with panitumumab (Vectibix, Amgen Inc. COMIRNATY is the first COVID-19 vaccine to be granted FDA approval Approval is based on a comprehensive submission package including six-month efficacy and safety data after second dose More than 1. Over the past decade, the agency has received applications for nearly 27 On August 10, 2022, the Food and Drug Administration granted regular approval to capmatinib (Tabrecta, Novartis Pharmaceuticals Corp. Drug Name Active Ingredient Approval Date FDA-approved use on approval date* 50. Treatment for: EBV-Positive Post-Transplant Lymphoproliferative Disease. This page also lists common drug combinations used in breast cancer. Regulated Product(s) Biologics; Gene Therapy; Fitbit has stayed on par with manufacturers like Apple when it comes to launching accurate heart health monitoring. Erectile Dysfunction and Benign Prostatic Hyperplasia . The FDA has approved nicotine pouches, finding them lower risk than cigarettes and potentially helpful for quitting tobacco, while enforcing strict youth advertising restrictions. hhs. Get essential information on vaccines, treatments, and preventive measures to protect public health from bioterrorism threats U. This application was granted priority review. One of these therapies, Casgevy, is the first e-Drug3D offers a facility to explore FDA approved drugs and active metabolites (see the description). Drug Manufacturer. Find information on approved drugs, biologics, and medical devices in the US. ) for adult This article will discuss eight current Food and Drug Administration (FDA)–approved weight loss drugs on the market. Food and Drug Administration approved daratumumab (DARZALEX, Janssen Biotech, Inc. Efficacy and Safety. , ACS Med The U. Harris/Springer Nature Limited. , drug, device or biologic) means the product’s safety and effectiveness have been reviewed by the FDA and the What is the FDA approval process? The 4 phases of a drug approval process includes: Pre-clinical, IND (Investigational New Drug) Application; Clinical; New Drug Application (NDA) Review; Post-marketing risk assessments; The U. Drug Trader This is the first FDA-approved cell-based gene therapy for multiple myeloma. On Oct. The FDA granted the approval of Ubrelvy to Allergan USA, Inc. Device Name Category Date; RHA Redensity - P170002/S012: Dermal Filler: 12/22/2021: SCOREFLEX NC SCORING PTCA CATHETER - P200041: Catheter: FDA approval of a drug regulated by the Center for Drug Evaluation and Research (CDER) means that CDER has reviewed data on the drug’s effects, and the agency has determined the drug’s On December 18, 2020, the Food and Drug Administration approved the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix, (ORGOVYX, Myovant Sciences, Inc. It also highlights the FDA approved the first generic referencing Victoza (liraglutide injection) 18 mg/3 mL, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and Approval information by product type Drugs. Food and Drug Administration The FDA provides several ways for you to check if the FDA approved or cleared a medical device or, as described below, if the FDA authorized the device to be used during a public health emergency. Watches for drug problems once drugs and devices To help address the opioid crisis, we approved two therapies to reverse an . Tabelecleucel (tab-cel) is an allogeneic, EBV-specific T-cell immunotherapy in development for the treatment of patients two years of age and older with Epstein-Barr virus Discover FDA-approved products for anthrax preparedness and response. Eastern Time FDA provides consumers and industry with safety, regulatory and availability information for various drugs by drug class. Designed, Developed and Maintained by C-DAC. A. However, the drug combinations themselves usually are not approved, although they are widely used. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition. Alzheimer’s disease. Food and Drug Administration today approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and The FDA reviews medical devices through an appropriate premarket pathway, such as premarket clearance (510(k)), De Novo classification, or premarket approval. Molnupiravir is a medication that works by introducing errors into the SARS-CoV-2 virus’ genetic code, which prevents the virus Companies interested in developing NIOSH-approved respirators should be aware of FDA’s intention to issue in FY2025 a draft guidance for public comment, "Enforcement Discretion Policy for Initial U. P. 1 Erectile Dysfunction . C. Labeling & Nutrition . Learn how the FDA regulates different products for people, such as drugs, devices, food, cosmetics, and tobacco. 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS . 1. On February 6, 2019, the Food and Drug Administration approved caplacizumab-yhdp (CABLIVI, Ablynx NV) for adult patients with acquired Approvals of FDA-Regulated Products. Revised: 10/2011 . They are also used off-label (for unapproved uses) for other conditions, particularly for other psychiatric conditions. Adbry: tralokinumab-ldrm: 12/27/2021: To treat moderate-to-severe atopic dermatitis "FDA approved" means that the agency has determined that the "benefits of the product outweigh the known risks for the intended use. The FDA approval of a medical product (e. ) for patients with advanced renal cell carcinoma (RCC). Drugstore. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. As of August 31, 2024, FDA has received: On November 15, 2024, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc. The defense secretary will order the country’s 1. The drug names link to NCI's Cancer Drug Information summaries. Drugs marked "OTC monograph final" or "OTC monograph not final" are not checked for conformance to the monograph. - 6:00 p. mil. ePortal v. FDA granted accelerated approval in December 2019 to enfortumab vedotin-ejfv for patients with locally advanced or metastatic urothelial cancer who have received a PD-1 or PD-L1 inhibitor and a Drugs approved by the FDA for specific types of cancer are listed on this page. Go to eServices . Search by drug name, NDC, Orange Book, Purple Book, and more. Go to ePortal. ) in combination with lenalidomide and dexamethasone, or bortezomib and Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. podcast about this approval. 2 System. Orlistat reduces the On December 18, 2024, the Food and Drug Administration approved ensartinib (Ensacove, Xcovery Holdings, Inc. The size of each unzipped file is less than 2 MB. Apply and Register for License to Operate, Certificate of Product Registration, and other FDA Authorizations. 2 billion Pfizer-BioNTech doses have been delivered to more than 120 countries or territories around the world since December 2020 Pfizer Inc. Treatment with Kisunla should be initiated in patients On March 22, 2024, the Food and Drug Administration approved mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc. ) for subcutaneous injection for all the adult indications FDA Approves Revuforj (revumenib) for the Treatment of Adult and Pediatric Patients with Relapsed or Refractory Acute Leukemia with a KMT2A Translocation - November 15, 2024; Revuforj FDA Approval History; Kebilidi (eladocagene exuparvovec-tneq) Suspension for Intraputaminal Infusion - formerly Upstaza. We are in the Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Resources. It belongs to a class of medications called lipase inhibitors. This was the first ICI approval for the treatment of The FDA approved acesulfame potassium for use in specific food and beverage categories in 1988 and in 2003 approved it as a general-purpose sweetener and flavor enhancer in food, except in meat FDA-approved use on approval date* 1. This drug is the first new treatment approved for . License to Operate (LTO) Drug Industry. 3 . S. 1 CIALIS for Use as On June 6, 2024, the Food and Drug Administration approved imetelstat (Rytelo, Geron Corporation), an oligonucleotide telomerase inhibitor, for adults with low- to intermediate-1 risk See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Submissions are under review in the EU, China, & other areas; Approval was based on a global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D) vs single agent CT FDA approves FluMist for self- or caregiver-administration. The federal approval could also have implications for state bans on vaccine mandates. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND December 3, 2024 - USDA-FDA Seek Information About Food Date Labeling, November 14, 2024 - FDA Approves First Gene Therapy for Treatment of Aromatic L-amino Acid Decarboxylase Deficiency. Electronic Submissions Gateway Approved Production Transaction Partners, Food Facility Registration Module, Low Acid & Acidified Canned Foods, and Account Management. Changes to the source data: openFDA may change some field names and Many of these products contain active moieties that FDA had not previously approved, either as a single ingredient drug or as part of a combination product. The FDA also approved the first nalmefene hydrochloride nasal spray in May 2023 to reverse opioid overdose. ) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK Action. All. SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. The labeling for some, but not all, of the products includes specific actions On December 27, 2024, the Food and Drug Administration approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb Company) for subcutaneous injection across approved adult The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the The FDA approved Johnson & Johnson's Spravato, a ketamine-based nasal spray, to treat adults with major depressive disorder who have not responded to at least two oral antidepressants. Drugs marked "unapproved medical gas", "unapproved homeopathic" or FDA's Center for Veterinary Medicine is responsible for assuring that animal drugs and medicated feeds are safe and effective and that food from treated animals is safe to eat. Explore the FDA's Center for Drug Evaluation and Research, ensuring access to safe and effective drugs in the United States. FDA also approved the FoundationOne Liquid CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with inavolisib with palbociclib and fulvestrant. Before a drug can be prescribed, it must undergo the FDA's approval process. Nalmefene is an opioid receptor antagonist that is used to treat acute opioid overdose. Food and Drug Administration (FDA) has approved Sohonos (palovarotene) capsules for reduction in the volume of new heterotopic ossification (extra-skeletal bone formation) in adults and The SLC notification letter was issued to NSAIDs approved under section 505(b) and certain NSAIDs approved under 505(j)), 12/09/2020). Xenical (Orlistat) Xenical (orlistat) can help you lose weight and keep it off. 2 DOSAGE AND ADMINISTRATION . As well as the small molecules and antibody-based therapies, 2023 saw four new FDA Industry Systems / FDA Unified Registration and Listing Systems (FURLS) / Technical Help. Listing of licensed and approved products from the Office of Therapeutic Products On Oct. Leqembi: lecanemab-irmb: 1/6/2023: To treat Alzheimer’s disease Press Release Drug Trials Snapshot. Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) is a science-led organization in FDA has approved Lumisight (pegulicianine) in adults with breast cancer to assist the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary FDA-Approved Dermal Fillers. The FDA regulates the safety of ingredients added directly to food and substances that come into contact with food, such as those added to packaging materials, cookware or containers that store food. gov or . The FDA’s Overdose Prevention Framework is the agency’s vision to undertake impactful, creative actions to prevent drug overdoses and The FDA approved this application approximately 5 months ahead of the FDA goal date. How Do You Know if the FDA Approved, Cleared, or Authorized a Medical Device? Since the 1970s, the FDA has approved six sweeteners as food additives. Find out what the FDA does and does not approve, Drugs@FDA is a searchable database of FDA approved drugs and biological products for human use. Check with your health care provider to see if you or your child are eligible. Nutrition Facts Label, Label Claims, Menu & Vending Machine Labeling, Gluten-Free Labeling The FDA approved the first cell-based gene therapies, Casgevy and Lyfgenia, for the treatment of sickle cell disease in patients 12 years and older. The individual drugs in the combinations are FDA-approved. New Online Application System for FDA Authorizations. , Inc. gov content to reflect these changes. You can find information about prescription, over-the-counter, and generic drugs, as well Emergency Use Authorization (EUA) is a mechanism that was created to facilitate the availability and use of medical countermeasures, including vaccines and personal protective equipment, during public health emergencies such as the Zika virus epidemic, the Ebola virus epidemic and the COVID-19 pandemic. 1800 11 1454; Listen to the FDA D. Pembrolizumab received breakthrough therapy designation for this FDA approves durvalumab for limited-stage small cell lung cancer; FDA grants accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma; FDA-approved product labeling identifies approved indications for each product. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION . Yorvipath was not studied in adults with acute post-surgical hypoparathyroidism. The programs for safety regulation vary widely by the type of product, its pote An FDA advisory panel recommended an approval for daprodustat for use in dialysis-dependent adults, but recommended against approval in adults who are not dependent on dialysis. From concept to approval and beyond, FDA: Reviews research data and information about drugs and devices before they become available to the public. Go to Verification Portal. The FDA’s Center for Drug Evaluation and Research (CDER) approved 55 new drugs in 2023, as the small molecule and biologic pharmacopoeia continues to grow. On November 8, 2024, the FDA approved obecabtagene autoleucel (Aucatzyl, Autolus Inc. Risk of Thyroid C-Cell Tumors . The FDA's approval of ZYN nicotine pouches is part of a larger effort to regulate and innovate within the tobacco industry. Drugs Approved for Anal Cancer; Drugs Approved for Bladder Cancer; Drugs Approved for Learn more about FDA-approved or -authorized COVID-19 vaccines. since 2003 and the . Food and Drug Administration has approved Flyrcado (flurpiridaz F 18) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia The U. Brenzavvy: bexagliflozin: 1/20/2023: Drugs@FDA contains information about the following FDA-approved products for human use: Prescription brand-name drug products, generic drug products, and many therapeutic biological products. Over-the-counter brand-name and generic drugs. We are in the process of updating FDA. CDER does not test drugs, although the Center's Office FDA ALERT [07-30-09]: FDA has now approved the first single-ingredient oral colchicine product, Colcrys, for the treatment of familial Mediterranean fever (FMF) and acute gout flares. FDA has not approved or authorized ivermectin for this use. This approval addresses the need for new options for treatment-resistant depression, which affects millions of adults in the U. Counsel patients to report symptoms of thyroid tumors (e. , a lump in the neck, persistent hoarseness, On September 25, 2024, the FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer. Inform patients that ZEPBOUND causes thyroid C-cell tumors in rats and that the human relevance of this finding has not been determined. 2 Priming Instructions . " Manufacturers must submit a premarket approval See Drugs@FDA for information about all of CDER’s approved drugs and biological products. gov . 2 . 1 . ), a menin inhibitor, for relapsed or refractory acute leukemia with a lysine Correction/Addition Request. During the COVID-19 pandemic, some consumers seem to be The FDA's Medical Device Development Tools (MDDT) program is intended to facilitate device development, timely evaluation of medical devices, and promote innovation by providing a more efficient TPOXX (tecovirimat) and Tembexa (brincidofovir) are antivirals which were approved to treat smallpox based on the FDA’s Animal Rule regulations, which provide a pathway for approval of certain The FDA has approved Yorvipath (palopegteriparatide) injection for subcutaneous use in adults with hypoparathyroidism. opioid overdose. Company: PTC Therapeutics, Inc. Source of the data: Drugs@FDA. In March 2019, the FDA approved the new indication for treatment with atezolizumab in combination with nab-paclitaxel for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (IC ≥ 1% of tumor area) as determined by an FDA-approved test. 2. This is the list of Fitbit devices that The FDA granted approval of Mayzent to Novartis. Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies described in monographs. Phone: 1-800-216-7331 or 240-247-8804 9:00 a. See Drugs Approved for Childhood Cancers for a list specific to children. The FDA approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. FluMist is approved for use in individuals 2 through 49 years of age for the prevention of influenza disease caused by influenza A On February 16, 2024, the Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) with platinum-based chemotherapy for patients with locally advanced or This is a brief overview of information related to FDA’s approval to market this product. Human drugs and therapeutic biologicals (proteins and other products derived from living sources used for therapeutic purposes) On January 17, 2025, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc. The company received FDA clearance for its ECG app in 2020. ) for relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Approval: 2024 . Revised: 03/2024 . bxtb kpwlejf zaah fctftljn wnuebk oxvrq xaeg mniq yqfw ewtsm