FDA Releases 19 Product-Specific Recommendations for Bioequivalence

The FDA has published 19 new product-specific recommendations for bioequivalence studies for ANDA applications, while revising another 19.

Among the drugs with new generic development recommendations are Genentech’s Cotellic for the treatment of metastatic melanoma, Eli Lilly’s Synjardy for the treatment of Type 2 diabetes and AstraZeneca’s Zurampic for the treatment of hyperuricemia associated with gout.

AbbVie’s pain reliever Vicodin — which contains the opioid hydrocodone — was among the 19 drugs with revised recommendations. The new recommendations for Vicodin significantly lower the dosage strength for which ANDA sponsors may request a waiver for in vivo testing.