FDA Provides ANDA Sponsors with BE Study Recommendations for 42 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On June 11, 2010, the FDA published its draft guidance entitled “Bioequivalence Recommendations for Specific Products.” This draft guidance “explained the process that would be used to make product-specific BE recommendations available to the public on FDA’s Web site.”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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