US FDA Sets Generic Approval Record, But Generic Sponsors Aren't Celebrating

FDA relates new record to its plan to increase access to affordable drugs, but Association for Accessible Medicines says approvals alone will not increase competition.

Bundle of money and pack of medication tablets or drug pills, close-up. Expensive health care concept, selective focus

The US FDA may be excited about breaking its record for generic drug approvals, but the industry's trade association cautioned that the metric may not be a bellwether for drug price reductions.

The agency reported 781 full ANDA approvals in in fiscal year 2018, which was 18 more than the previous GDUFA-era...

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