FDA Says Diastat Not Withdrawn From Sale For Safety, Effectiveness; Will Approve ANDAs

Certain strengths of Diastat (diazepam rectal gel) were not withdrawn from sale for reasons of safety or effectiveness, the Food and Drug Administration said in a Aug. 18 Federal Register notice (75 Fed. Reg. 51080).

Diastat, which was manufactured by Valeant Pharmaceuticals International, is an anticonvulsant agent indicated for use in the management of selected refractory patients with epilepsy, on stable regimens of antiepileptic drugs, who require intermittent use of diazepam to control bouts of increased seizure activity. Valeant discontinued marketing Diastat in the 5 milligrams (mg)/milliliter (mL), 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 ...