FDA on bioequivalents

July 1, 2015

Generic drug manufacturers have been given a boost by the US Food and Drug Administration (FDA) supporting a new batch of bioequivalence recommendations, according to the Regulatory Affairs Professionals Society (RAPS). Drugs likely to be targeted early include Sovaldi (sofosbuvir), Northera (droxidopa), Xtandi (enzalutamide) and Olysio (simeprevir) under an Abbreviated New Drug Application (ANDA). Solvadi is one of the top selling drugs by total revenue and is therefore expected to attract significant interest. The FDA has identified around 45 drugs that could be affected by the new recommendations.

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Pharmacy Daily | FDA on bioequivalents

FDA on bioequivalents

Other recent headlines

PD breaking news – Pharmacists to administer NIP vaccinations in aged care

PD breaking news – Top Western Australian talent honoured

Legal action for Montu

SEARCH PHARMACY DAILY

Featured video

Recent issues

INDUSTRY JOB VACANCIES