On June 11, 2010, the FDA published its draft guidance entitled “Bioequivalence Recommendations for Specific Products.” This draft guidance “explained the process that would be used to make product-specific BE recommendations available to the public on FDA’s Web site.”
On January 28, 2016, FDA published product-specific recommendations regarding the design of bioequivalence (BE) studies used to support abbreviated new drug applications (ANDAs). The BE recommendations identified in FDA’s guidance were developed using the process described in the June 2010 guidance.
FDA’s guidance contains [new] draft recommendations for 31 different active pharmaceutical ingredients (APIs), including:
- Alprostadil
- Atazanavir sulfate; cobicistat
- Beclomethasone dipropionate
- Betamethasone dipropionate
- Betamethasone valerate
- Betaxolol hydrochloride
- Ciclesonide
- Clobetasol propionate
- Desonide (multiple reference listed drugs)
- Diflorasone diacetate (multiple reference listed drugs)
- Difluprednate emulsion
- Elvitegravir
- Erythromycin
- Ethinyl estradiol; norethindrone acetate
- Flurandrenolide
- Formoterol fumarate; mometasone furoate
- Ingenol mebutate (multiple strengths)
- Mercaptopurine
- Methylphenidate hydrocholoride
- Metronidazole
- Mometasone furoate
- Naftifine hydrochloride (multiple reference listed drugs)
- Nicotine
- Olanzapine pamoate
- Omega-3-carboxylic acids
- Prednisone
- Ranitidine hydrochloride
- Riociguat
- Spinosad
- Trametinib dimethyl sulfoxide
- Vorapaxar sulfate
In addition, the Agency also released revised draft recommendations for the following 11 APIs:
- Abiraterone acetate
- Amphotericin B
- Ciprofloxacin hydrochloride; hydrocortisone
- Colesevelam hydrochloride
- Drospirenone; estradiol
- Guanfacine hydrochloride
- Lamotrigine
- Lidocaine
- Lomitapide mesylate
- Methylphenidate hydrochloride
- Phytonadione
- Rivastigmine tartrate
FDA is seeking feedback from the public and will be accepting comments until March 28, 2016.
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