FDA Adds 31 Bioequivalence Guidances, Revises 13; EMA Releases 5 Guidelines

The FDA published 31 new product-specific guidances for bioequivalence and revised another 13, while the EMA added five guidelines.

Among the drugs with new guidances are Swedish Orphan Biovitrum’s Orfadin for the treatment of the metabolic disorder tyrosinemia type 1, Takeda’s Colcrys for the treatment and prevention of gout attacks and Medicis Pharmaceutical’s Vanos for the treatment of skin disorders and relief of pain, itching, and swelling of the skin.

Valeant’s herpes therapy Zovirax — which contains the active ingredient acyclovir — was among the 13 drugs with revised recommendations. GSK’s bronchial spasm drug Ventolin and Merck’s skin infection treatment Sivextro were also included on the list of revised guidances.