Orchid receives FDA OK for divalproex delayed-release tablets
This article was originally published in Scrip
Executive Summary
Orchid Chemicals & Pharmaceuticalshas received approval from the US FDAfor its ANDA for divalproex sodium delayed-release tablets 125mg, 250mg and 500mg, generic versions of Abbott Laboratories' Depakote tablets. Divalproex sodium delayed-release tablets are indicated as monotherapy and adjunctive therapy in the treatment of complex partial seizures, as sole and adjunct therapy for patients with simple and complex absence seizures, for the treatment of the manic episodes associated with bipolar disorders, as well as for prophylaxis of migraine headaches. In July this year, the FDA approved about eight generic versions of Depakote tablets, including those of the Indian companies Sun Pharmaceutical Industries, Lupin and Dr Reddy's Laboratories.