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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Milla Pharmaceuticals, part of the Alter Pharma Group, toasted three milestones as it announced approval and launch of its generic version of Pfizer’s sodium acetate 2mEq/ml injectable in the US.
Forecasting up to a dozen complex generic launches by Teva in the US in 2021, executive vice-president for North America commercial Brendan O’Grady said Teva was continuing to push for changes to boost approval rates ahead of GDUFA III next year.
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.