ANI Pharma Launches Oxycodone Capsules; FDA Approves Oxcarbazepine Tablets

(RTTNews) - ANI Pharmaceuticals, Inc. (ANIP) announced Monday the commercial launch of Oxycodone HCl Capsules, 5mg. Trailing twelve-month sales for the product are $7.5 million according to IMS Health.

The company noted that it is the third Schedule II narcotic product to the company's commercial portfolio and sixth new product introduction in the second quarter of 2016.

Oxycodone hydrochloride is an opioid agonist indicated for the management of moderate to severe acute and chronic pain where the use of an opioid analgesic is appropriate.

Separately, the company said it has received approval from the U.S. Food and Drug Administration of the Prior Approval Supplement for Oxcarbazepine Tablets, 150mg, 300mg and 600mg. The current annual U.S. market for this product, based on trailing twelve months sales, is $145 million according to IMS Health.

Arthur Przybyl, ANI's President and CEO said, "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."

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.