ANDA Approval Records Likely To End
Record Approvals Expected To End As US FDA Mops Up Backlog
CDER director Woodcock says generic approvals remain inflated by applications that languished before FDA’s user fee program began, but as sponsors work through their own backlog of FDA responses, the number of ANDAs cleared by the agency appears likely to fall.
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The April total is the highest monthly total in seven months, but only a few are first generics. Approval volume might continue rising if FDA does not find too many applications requiring in-person inspections, which were largely postponed as part of coronavirus containment measures, Robert Pollock, senior advisor and outside director to the board at Lachman Consultants, said.
US FDA reports another low tally of full approvals in October, but stakeholders are not worried given the agency's history of record-breaking totals year over year.
The record number of full ANDA approvals also exceeded submissions for the first time since GDUFA was enacted.