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Home » Court Supports FDA on Approval Revocation, but Blasts Processes
Court Supports FDA on Approval Revocation, but Blasts Processes
A federal judge upheld the FDA’s decision to strip Ranbaxy of its tentative ANDA approvals and first-filer rights to two drugs because of GMP problems at manufacturing facilities, but nonetheless blasted the agency, saying it never should have issued the approvals in the first place.