FDA Offers New Bioequivalence Recommendations for 31 Active Ingredients, 13 Revisions

The US Food and Drug Administration (FDA) on Thursday announced the latest batch of new draft guidance for the generic drug industry with 31 product-specific bioequivalence (BE) recommendations and 13 revisions to prior recommendations.

The recommendations, which have been released on an ongoing basis since 2010, provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs).

The new guidance is for the following active ingredients:
1. Adapalene; benzoyl peroxide
2. Amphetamine
3. Betamethasone valerate
4. Budesonide
5. Cephalexin
6. Cetirizine hydrochloride
7. Clozapine
8. Colchicine
9. Doxycycline hyclate
10. Emtricitabine; Rilpivirine hydrochloride; Tenofovir alafenamide fumarate
11. Emtricitabine; Tenofovir alafenamide fumarate
12. Epinephrine
13. Esomeprazole Magnesium
14. Ethiodized oil
15. Fenofibrate
16. Fluocinonide
17. Fluoxetine hydrochloride
18. Halcinonide
19. Ibuprofen; pseudoephedrine hydrochloride
20. Lidocaine
21. Morphine sulfate
22. Nicotine polacrilex
23. Nitisinone
24. Omega-3-acid ethyl esters type A
25. Oxycodone
26. Panobinostat lactate
27. Perampanel
28. Pimavanserin tartrate
29. Prazosin hydrochloride
30. Simvastatin
31. Tofacitinib citrate

And the revised draft product-specific BE recommendations include: Acyclovir; Albuterol sulfate; Buprenorphine hydrochloride, Naloxone hydrochloride (multiple reference listed drugs); Cobicistat, Darunavir ethanolate; Divalproex sodium (multiple reference listed drugs); Levomilnacipran hydrochloride; Medroxyprogesterone acetate; Nepafenac (multiple reference listed drugs); Omega-3-acid ethyl esters; Omega-3-carboxylic acids; Ruxolitinib phosphate; Tedizolid phosphate; and Venlafaxine hydrochloride.

The federal docket of previous BE product-specific recommendations can be viewed here and the specific guidance documents can be viewed at Product-Specific Recommendations for Generic Drug Development.