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 are safe and effective medications for treating many illnesses such as arthritis and cancer. Learn about biosimilars and how they benefit 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 …
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 …
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 ...
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
93 first generics and 75+ original ANDAs approved under prioritized assessment of generic drug application submissions for COVID-19 108 pre-ANDA meeting requests answered