FDA’s OGD Takes Fight To COVID-19 With Half-Century Of Approvals
Six-Dozen First Generics Approved Last Year Including $3.3bn Tecfidera
The sixth annual report of the FDA’s Office of Generic Drugs covered a year dominated by the novel coronavirus pandemic – although first-time generic approvals and record levels of communication also featured prominently.
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Slayback Pharma has now launched its Merzee generic version of Allergan’s Taytulla oral contraceptive with a CGT designation, several months after Xiromed moved first.
As part of a wider overhaul of the FDA’s Center for Drug Evaluation and Research, the agency is reorganizing its Office of Generic Drugs, including adding a new Office of Safety and Clinical Evaluation within the OGD.
Amphastar has secured the first US approval for a generic version of Eli Lilly’s glucagon emergency kit.