Generic Drugs: Questions & Answers | FDA
Generic Drug Facts At-a-glance information on generic medicines, including why they may look different or cost less than brand-name medicines.
FDA List of Authorized Generic Drugs
The FDA List of Authorized Generics page answers what an authorized generic is and how it differs from a traditional generic. An authorized generic is used to describe an approved brand …
Generics (typically small molecules) and biosimilars (typically larger, more complex molecules) are approved through different abbreviated pathways that avoid duplicating certain costly …
Biosimilars Basics for Patients | FDA
Biosimilars and generics are both versions of previously FDA approved medications and may offer more affordable treatment options to patients.
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Gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) FDA warns about serious breathing problems for … imaging Sept. 21, 2015 Ultram, Ultram ER, Conzip, and …
Guidance for Industry 180-Day Exclusivity: Questions and Answers
GenericsGUIDANCE DOCUMENT Guidance for Industry 180-Day Exclusivity: Questions and Answers January 2017
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA
What Is the Approval Process for Generic Drugs? | FDA
Generic drugs are copies that one company makes of a brand-name drug that was developed by another company. Generally, generic drugs sell at lower prices, and it is in the public's interest …
Office of Generic Drugs 2022 Annual Report | FDA
In 2022, generic drugs remained a significant public health priority for the FDA. Competition from generic drug makers helped make drugs more widely available and generally less expensive ...
This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug …