Labeling supplement (NDA 21-076/S7) for naproxen sodium 220 mg/extended-release pseudoephedrine 120 mg combination approved by FDA July 31. Bayer says agency asked it to file formal supplement to add the Sinus & Headache sub-brand under previously approved NDA for Aleve Cold & Sinus; both products contain the same formulation. Sinus & Headache began shipping in July 2001 (1"The Tan Sheet" July 9, 2001, p. 3)...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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The FDA's Oncologic Drugs Advisory Committee will consider whether appropriate dosages of belantamab mafodotin have been identified for two second-line, multiple myeloma indications. Ocular toxicities and large number of dose modifications in trials raised FDA concerns about benefit-risk.
The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.