The US FDA has issued draft bioequivalence guidelines for nearly 50 active pharmaceutical ingredients (API) in a notice in the Federal Register.
The new draft guidelines – which cover a wide range of ingredients (see fact box) – are intended as a guide for generic drugmakers designing bioequivalence (BE) studies to support abbreviated new drug application (ANDA) submissions.
The Food and Drug Administration (FDA) has been publishing product specific BE guidelines since 2010 when it concluded that making such information available, rather than requiring that drugmakers request it, was more efficient.
The new set of guidelines is accompanied by several revised versions of previously published BE recommendations (section III).
New BE guides for the following APIs:
Amoxicillin; clavulanate potassium
Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateShow citation box
Bupropion hydrochloride (multiple reference listed drugs (RLDs))
Estramustine phosphate sodium
Mesalamine (multiple RLDs and dosage forms)
Methylphenidate hydrochloride (multiple RLDs)
Omega-3-acid ethyl esters
Tenofovir disoproxil fumarate
Tretinoin (multiple RLDs and dosage forms)