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)