ANI Pharmaceuticals Gets FDA Approval For Oxcarbazepine Tablets

ANI Pharmaceuticals, Inc. ANIP received approval from the Food and Drug Administration of the Prior Approval Supplement for Oxcarbazepine Tablets, 150mg, 300mg and 600mg. According to the company, the current annual market for this product, based on trailing twelve months sales, was $145 million in the United States based IMS Health.

ANI Pharmaceutical's President and CEO, Arthur Przybyl, stated, "This approval is the result of ANI's ongoing effort to re-activate the discontinued ANDAs that we have acquired in recent years. The PAS included the successful qualification of a new API source for the drug substance as well as the addition of manufacturing and packaging at ANI's Baudette site."

The company indicated Oxcarbazepine is an antiepileptic drug indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and as monotherapy in the treatment of partial seizures in children aged 4 years and above with epilepsy, and as adjunctive therapy in children aged 2 years and above with partial seizures.

In pre-market trading, the stock traded 1.83 percent higher.