FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Publishes 30 New Product-Specific Bioequivalence Recommendations; Revises 30

Oct. 11, 2016

The FDA has published 30 new product-specific recommendations on the design of bioequivalence studies for ANDAs, while also revising 30 of its previous recommendations.

Among the reference drugs with new recommendations for generic development are UCB’s Atamet for the treatment of Parkinson’s disease; Tesaro’s Varubi for the treatment of vomiting and nausea associated with chemotherapy; and GlaxoSmithKline’s Incruse Ellipta for the treatment of chronic obstructive pulmonary disorder.

Pfizer’s heartburn drug Protonix, which reduces the amount of acid produced by the stomach, is among the 30 drugs with revised recommendations. The new recommendations for Protonix address the development of a tube, which would be comparable to the reference product, to administer the drug.

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