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

Posted 22 December 2016 By Zachary Brennan

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The US Food and Drug Administration (FDA) on Thursday announced the latest batch of new draft guidance for the generic drug industry with 31 product-specific bioequivalence (BE) recommendations and 13 revisions to prior recommendations.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

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Categories: Active pharmaceutical ingredients, News, US, FDA

Tags: BE studies, generic drug guidance from FDA, active ingredients

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