FDA Offers New Bioequivalence Study Guidance for 31 Generic Drug Ingredients

Regulatory NewsRegulatory News | 27 January 2016 |  By 

To help the generic pharmaceutical industry identify the most appropriate ways to generate evidence needed to support abbreviated new drug application (ANDA) approval, the US Food and Drug Administration (FDA) has published draft product-specific recommendations for 31 different active pharmaceutical ingredients (APIs) and revised recommendations for 11 APIs.

The myriad new draft guidance documents focus on what types of bioequivalence (BE) studies may need to be conducted to obtain ANDA approval. Each document also contains information on what analytes should be measured, what dissolution test methods should be used and sampling times.

“Different types of evidence may be used to establish bioequivalence for pharmaceutically equivalent drug products, including in vivo or in vitro testing, or both,” FDA says. “The selection of the method used to demonstrate bioequivalence depends upon the purpose of the study, the analytical methods available, and the nature of the drug product.  

New draft guidance was released for the following APIs:

  • 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

The agency also released revised recommendations for the following APIs:

  • Abiraterone acetate
  • Amphotericin B
  • Ciprofloxacin hydrochloride; hydrocortisone
  • Colesevelam hydrochloride
  • Drospirenone; estradiol
  • Guanfacine hydrochloride
  • Lamotrigine
  • Lidocaine
  • Lomitapide mesylate
  • Methylphenidate hydrochloride
  • Phytonadione
  • Rivastigmine tartrate

The agency also pointed industry to draft guidance from 2013 as the initial step for selecting methodology for generic drug product development. 

The public has two months to submit comments on the recommendations before they are made final. Comments should be submitted to the Division of Dockets Management (DDM) under Docket FDA-2007-D-0369-0015.

Product-Specific Recommendations for Generic Drug Development

Federal Register Notice


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