Schering betamethasone withdrawals
Executive Summary
FDA determines Jan. 11 that Schering-Plough's Celestone Soluspan (betamethasone sodium phosphate/betamethasone acetate) and Celestone (betamethasone sodium phosphate) were not withdrawn due to safety and efficacy issues; the two betamethasone products were withdrawn due to manufacturing issues, agency says. The determination allows the agency to approve abbreviated NDAs for betamethasone sodium phosphate/betamethasone acetate and for betamethasone sodium phosphate injections if all other regulatory requirements are met. In the interim, Celestone Soluspan will only be available in "certain instances of medical necessity only," FDA says...
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