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About [email protected] FDA

Details: Drugs@FDA includes most of the drug products approved since 1939. The majority of patient information, labels, approval letters, reviews, and other information are available for drug products

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[email protected]: FDA-Approved Drugs

Details: * Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products).

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Find Information about a Drug FDA

Details: Find Drug Information on MedlinePlus. Easy-to-use resource from NIH with information about side effects, dosage, special precautions, and more for prescription and OTC drugs

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Drug Approvals and Databases FDA

Details: CDER highlights key Web sites. Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting. Additional topics include: approved

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Guidances (Drugs) FDA

Details: Newly added and withdrawn guidances can be found at Guidances (Drugs). FDA guidance documents discuss the production, labeling, manufacturing of regulated products and denote FDA's current

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Search for Regulatory References Drugs FDA

Details: Generic Drugs, Abbreviated New Drug Application (ANDA) Referencing Approved Drug Products in ANDA Submissions Guidance for Industry Self-Identification of Generic Drug Facilities, Sites and

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Guidance, Compliance, & Regulatory Information FDA

Details: Looking for FDA Guidance, Compliance, & Regulatory Information? Web page provides quick links to a variety of topics including nicotine-containing products, human drug compounding, and the

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Coronavirus (COVID-19) Drugs FDA

Details: Antiviral Drugs Antiviral drugs are prescription medicines (pills, liquid, an inhaled powder, or an intravenous solution) that fight against viruses in your body.

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U.S. Food and Drug Administration

Details: 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

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FDA approves drug to treat smallpox FDA

Details: Fast track is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Orphan drug designation provides incentives to

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What's New Related to Drugs FDA

Details: Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.

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[email protected] Glossary of Terms FDA

Details: In general, the term "drugs" includes therapeutic biological products. Brand Name Drug A brand name drug is a drug marketed under a proprietary, trademark-protected name.

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Information for Consumers and Patients Drugs FDA

Details: Drugs@FDA: Approval, labeling, side effects, and safety: Drugs with Approved Risk Evaluation and Mitigation Strategies (REMS) Approval, labeling, side effects, and safety: Index to Drug-Specific

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FDA grants accelerated approval to mobocertinib for

Details: On September 15, 2021, the Food and Drug Administration granted accelerated approval to mobocertinib (Exkivity, Takeda Pharmaceuticals, Inc.) for adult patients with locally advanced or metastatic

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CDER: The Consumer Watchdog for Safe and Effective Drugs FDA

Details: Generic Drugs. A generic drug is a chemical clone of a drug sold under a brand name. There are generic versions of both prescription and OTC medicines. For example, ibuprofen is the generic name

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FDA Ensures Equivalence of Generic Drugs FDA

Details: Generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies (according to the Congressional Budget Office). Even more billions are saved when hospitals use generics

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Resources for Information Approved Drugs FDA

Details: Drugs@FDA includes most of the drug products approved since 1939. The majority of patient information, labels, approval letters, reviews, and other information are available for drug products

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FDA approves belumosudil for chronic graft-versus-host

Details: FDA approves belumosudil for chronic graft-versus-host disease. On July 16, 2021, the Food and Drug Administration approved belumosudil (Rezurock, Kadmon Pharmaceuticals, LLC), a kinase inhibitor

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[email protected]: FDA-Approved Drugs

Details: U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA

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Meetings, Conferences, & Workshops Drugs FDA

Details: Workshop. 12/02/2021. 12/02/2021. December 2, 2021: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement. Advisory Committee …

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[email protected]: FDA-Approved Drugs

Details: Recent New and Generic Drug Approvals. This report displays final approvals and tentative approvals of original and supplemental applications for the two weeks beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this timespan. For comprehensive approval reports, please use the monthly " All

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FDA approves drug to reduce risk of serious kidney and

Details: FDA has approved Kerendia (finerenone) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal hearts attacks, and hospitalization for heart failure

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Development & Approval Process Drugs FDA

Details: Since the Accelerated Approval pathway was established in 1992, many drugs that treat life-threatening diseases have successfully been brought to market this way and have made a significant impact

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Coronavirus Aid, Relief, and Economic Security Act (CARES

Details: In addition to human drugs approved under section 505 of the FD&C Act, and animal drugs approved under section 512, conditionally approved under section 571 or indexed under section 572 of the FD

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Human Drugs FDA

Details: The Center for Drug Evaluation and Research (CDER) is the FDA Center responsible for overseeing the drug program which includes over-the-counter and prescription drugs, including biological

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Electronic Drug Registration and Listing Instructions FDA

Details: Drugs are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as the FDA’s universal product identifier for drugs.

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News & Events for Human Drugs FDA

Details: 10001 New Hampshire Ave. Hillandale Building, 4th Fl. Silver Spring, MD 20993. [email protected] Toll Free. (855) 543-3784. (301) 796-3400. Hours Available. CDER Division of Drug Information.

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New Class of Drugs Fulfills Promise of RNA-based Medicine

Details: These drugs also require a delivery system such as a lipid nanoparticle to get the drug to specific target tissues. Patisiran is encased in a lipid nanoparticle, which carries and delivers the

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Approved Drugs: Questions and Answers FDA

Details: Drugs@FDA contains most of the drug products approved since 1939. Related Information. FAQs about the FDA Drug Approval Process; Everything you always wanted to …

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FDA approves new dosing regimen for cetuximab FDA

Details: On April 6, 2021, the Food and Drug Administration approved a new dosage regimen of 500 mg/m 2 as a 120-minute intravenous infusion every two weeks (Q2W) for cetuximab (Erbitux, ImClone LLC) for

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FDA’s Decision to Approve New Treatment for Alzheimer’s

Details: We know that the Peripheral and Central Nervous System Drugs Advisory Committee, which convened in November 2020 to review the clinical trial data and discuss the evidence supporting the Aduhelm

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Understanding Over-the-Counter Medicines FDA

Details: Understanding Over-the-Counter Medicines. Over-the-counter medicine is also known as OTC or nonprescription medicine. All these terms refer to medicine that you can buy without a prescription

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Withdrawn Guidances (Drugs) FDA

Details: Withdrawn Guidances (Drugs) Export Excel. Title. Date Issued. Date Withdrawn. Attachment D – Application, Product, and Establishment Fees: Common Issues and Their Resolution. 12/16/1994. 11/08/2017. Accelerated Approval Products —Submission of Promotional Materials.

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FDA approves olaparib for HRR gene-mutated metastatic

Details: On May 19, 2020, the Food and Drug Administration approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals, LP) for adult patients with deleterious or suspected deleterious germline or somatic

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FDA grants accelerated approval to loncastuximab tesirine

Details: On April 23, 2021, the Food and Drug Administration granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics SA), a CD19-directed antibody and alkylating agent

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FDA Insight: Compounded Drugs FDA

Details: Drugs that are compounded in outsourcing facilities are subject to FDA quality standards from manufacturers known as good manufacturing practice requirements. By contrast, drugs that are

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FDA approves nivolumab for adjuvant treatment of

Details: FDA approves nivolumab for adjuvant treatment of urothelial carcinoma. On August 19, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Co.) for the adjuvant

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FDA and Cannabis: Research and Drug Approval Process FDA

Details: For certain drugs that have not been approved by the FDA, the lack of FDA approval and oversight means the safety, effectiveness, and quality of the drug – including how potent it is, how pure

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Natural Disaster Preparedness and Response Drugs FDA

Details: Natural Disaster Preparedness and Response | Drugs. en Español. The FDA reminds consumers to have an emergency plan and to take precautions for storing water and ensuring the safety of their food

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HIV and AIDS: Medicines to Help You FDA

Details: For more information about the risks and side effects for each medicine, check Drugs@FDA. This information does not give the specific side effects or warnings for each medicine.

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FDA approves nivolumab for resected esophageal or GEJ

Details: On May 20, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for patients with completely resected esophageal or gastroesophageal junction (GEJ

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FDA approves weight management drug for patients aged 12

Details: FDA approves weight management drug for patients aged 12 and older. [12/4/2020] The U.S. Food and Drug Administration has approved a supplemental indication for Saxenda (liraglutide) for chronic

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[email protected]: FDA-Approved Drugs

Details: a-hydrocort. a-hydrocort (hydrocortisone sodium succinate) | anda #040666 | injectable;injection | hospira a-hydrocort (hydrocortisone sodium succinate) | anda #085928 | injectable;injection | abbott a-hydrocort (hydrocortisone sodium succinate) | anda #085929 | injectable;injection | hospira a-hydrocort (hydrocortisone sodium succinate) | anda #085930 | injectable;injection | hospira

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[email protected]: FDA-Approved Drugs

Details: carbamazepine. carbamazepine (carbamazepine) | anda #070231 | tablet;oral | inwood labs carbamazepine (carbamazepine) | anda #070300 | tablet;oral | usl pharma

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[email protected]: FDA-Approved Drugs

Details: valacyclovir hydrochloride. valacyclovir hydrochloride (valacyclovir hydrochloride) | anda #076588 | tablet;oral | sun pharm inds ltd valacyclovir hydrochloride (valacyclovir hydrochloride) | anda #077478 | tablet;oral | sandoz valacyclovir hydrochloride (valacyclovir hydrochloride) | anda #077135 | tablet;oral | cipla valacyclovir hydrochloride (valacyclovir hydrochloride) | anda #077655

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Gastrointestinal Drugs Advisory Committee Roster FDA

Details: Applying for Membership on FDA Advisory Committees. As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of interest who

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