Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Fabre-Kramer Pharmaceuticals Inc. (Fabre-Kramer), a biopharmaceutical company announced approval of Exxua™ (gepirone hydrochloride extended-release tablets) a new class of antidepressant. The approval comes after years of review over efficacy concerns between FDA and the drug’s sponsors.
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