US FDA issues new BE guidelines for 50 APIs

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

Amoxicillin; clavulanate potassium

Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateShow citation box

Budesonide

Bupropion hydrochloride (multiple reference listed drugs (RLDs))

Calcitonin salmon

Carbidopa; levodopa

Carglumic acid

Ciclesonide

Ciprofloxacin; dexamethasone

Cyclophosphamide

Dalteparin sodium

Estramustine phosphate sodium

Fentanyl citrate

Ketoconazole

Linagliptin

Mesalamine (multiple RLDs and dosage forms)

Methylphenidate hydrochloride (multiple RLDs)

Nifedipine

Omega-3-acid ethyl esters

Omeprazole

Paclitaxel

Pazopanib hydrochloride

Progesterone

Rilpivirine hydrochloride

Roflumilast

Saxagliptin hydrochloride

Telaprevir

Tenofovir disoproxil fumarate

Thioguanine

Thalidomide

Tretinoin (multiple RLDs and dosage forms)