FDA Provides ANDA Sponsors with BE Study Recommendations for 42 Generic Drug Ingredients


FDA published 31 new & 11 revised draft bioequivalence (BE) recommendations for generic drug ingredients

On June 11, 2010, the FDA published its draft guidance entitled “Bioequivalence Recommendations for Specific Products.” This draft guidance “explained the process that would be used to make product-specific BE recommendations available to the public on FDA’s Web site.”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:

  1. Alprostadil
  2. Atazanavir sulfate; cobicistat
  3. Beclomethasone dipropionate
  4. Betamethasone dipropionate
  5. Betamethasone valerate
  6. Betaxolol hydrochloride
  7. Ciclesonide
  8. Clobetasol propionate
  9. Desonide (multiple reference listed drugs)
  10. Diflorasone diacetate (multiple reference listed drugs)
  11. Difluprednate emulsion
  12. Elvitegravir
  13. Erythromycin
  14. Ethinyl estradiol; norethindrone acetate
  15. Flurandrenolide
  16. Formoterol fumarate; mometasone furoate
  17. Ingenol mebutate (multiple strengths)
  18. Mercaptopurine
  19. Methylphenidate hydrocholoride
  20. Metronidazole
  21. Mometasone furoate
  22. Naftifine hydrochloride (multiple reference listed drugs)
  23. Nicotine
  24. Olanzapine pamoate
  25. Omega-3-carboxylic acids
  26. Prednisone
  27. Ranitidine hydrochloride
  28. Riociguat
  29. Spinosad
  30. Trametinib dimethyl sulfoxide
  31. Vorapaxar sulfate

In addition, the Agency also released revised draft recommendations for the following 11 APIs:

  1. Abiraterone acetate
  2. Amphotericin B
  3. Ciprofloxacin hydrochloride; hydrocortisone
  4. Colesevelam hydrochloride
  5. Drospirenone; estradiol
  6. Guanfacine hydrochloride
  7. Lamotrigine
  8. Lidocaine
  9. Lomitapide mesylate
  10. Methylphenidate hydrochloride
  11. Phytonadione
  12. Rivastigmine tartrate

FDA is seeking feedback from the public and will be accepting comments until March 28, 2016.

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