Drug approvals for Orchid and Sun

Granisetron hydrochloride tablets
Orchid Chemicals & Pharmaceuticals Ltd has received approval from the USFDA for its ANDA (Abbreviated New Drug Application) for Granisetron hydrochloride tablets. The product is available in 1 mg dosage strength. It is the first Indian company to be approved for this non-antibiotic product. An anti-emetic product, Granisetron is a new generation non-antibiotic product. With limited generic competition, Orchid hopes to garner a strong market share leading to a sizeable revenue contribution from this product.

Divalproex sodium delayed release tablets
The USFDA has granted tentative approval for Sun Pharmaceutical' Abbreviated New Drug Application (ANDA) for generic Depakote, divalproex sodium delayed release tablets. Divalproex sodium delayed release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with 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.These generic versions of divalproex sodium delayed release 125 mg, 250 mg and 500 mg (valproic acid activity) tablets are bio-equivalent to Depakote delayed release tablets distributed by Abbott Laboratories. These strengths of Depakote delayed release tablets have annual sales of approximately USD 755 million in the US.