Aurobindo gets final nod for CNS drug

Aurobindo Pharma Ltd, a Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients, has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Divalproex Sodium Delayed-Release tablets USP in 125 mg, 250 mg and 500 mg strengths.

The new approval takes USFDA’s total abbreviated new drug applications (ANDA) approvals to Aurobindo to 135 (104 final and 31 tentative).

Divalproex Sodium Delayed-Release tablets are the generic equivalent of Abbott Laboratories’ Depakote Delayed-Release tablets. The product has a market size of $144 million and will be launched soon, the company said in a filing to the BSE on Monday.

 

The generic equivalent falls under the neurological (central nervous system) therapeutic category indicated for the treatment of manic episodes associated with bipolar disorder and as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in the association with other types of seizures and for prophylaxis of migraine headaches.

Aurobindo Pharma’s scrip is currently trading at Rs 197.55 on the BSE, up 1.28 per cent, over the previous close of Rs 195.05.