Generic Drug Facts | FDA
Nov 1, 2021 · Generic drugs must meet the same high standards as brand-name drugs to receive FDA approval. FDA requires drug companies to demonstrate that the generic medicine can be …
Generic Drugs: Questions & Answers | FDA - U.S. Food and Drug ...
A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, …
Generic Drugs | FDA - U.S. Food and Drug Administration
Understanding generic drugs: Consumer-friendly information on the safe and effective use of generic drugs. Learn about the generic drug approval process, why generic drugs are usually …
Overview & Basics | FDA - U.S. Food and Drug Administration
The FDA Office of Generic Drugs follows a rigorous review process to make sure that, compared to the brand-name (or innovator) medications, the proposed generic medications:. Contain the …
FDA List of Authorized Generic Drugs | FDA - U.S. Food and Drug ...
Oct 8, 2024 · An authorized generic is used to describe an approved brand name drug that is marketed as a generic product without the brand-name, or trade name, on the label. It is the ex.
Generic Drugs: What Everyone Should Know | FDA - U.S. Food and …
According to the U.S. Food and Drug Administration (FDA), a generic drug is a copy that is identical to a brand-name drug in dosage, safety, strength, how it is taken, quality, …
FDA approves first generics of Eliquis | FDA - U.S. Food and Drug ...
“Today’s approvals of the first generics of apixaban are an example of how the FDA’s generic drug program improves access to lower-cost, safe and high-quality medicines,” said Janet ...
Date Authorized Generic Entered the Market 104 ARICEPT ODT Orally distinegrating tablets 5 mg Eisai, Inc. 10/18/2009 - 11/24/2010 105 ARIXTRA Injection 2.5 mg / 0.5 mL Mylan Ireland …
The Generic Drug Approval Process - FDA
How do generic drugs reduce the overall cost of medication in the U.S.? Usually, as FDA approves more generics of a brand-name drug, the cost drops. Generally, multiple generic …
FDA Ensures Equivalence of Generic Drugs | FDA - U.S. Food and …
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 …