Home » FDA Panel Favors Chelsea’s Northera Drug Despite Some Reservations
FDA Panel Favors Chelsea’s Northera Drug Despite Some Reservations
An FDA advisory panel voted 7–4 with one abstention to recommend approval of Chelsea Therapeutics’ Northera, arguing a high unmet medical need outweighs safety concerns and a lack of long-term efficacy data. The drug is under review to treat low blood pressure in patients with nervous system disorders.
Washington Drug Letter
Washington Drug Letter
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