ANI Pharmaceuticals (ANIP)

[big bambino]

ANI Pharmaceuticals Announces FDA Approval of Oxcarbazepine Tablets
1 hour 20 minutes ago - DJNF

BAUDETTE, Minn., June 13, 2016 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it has received approval from the U.S. Food and Drug Administration ("FDA") of the Prior Approval Supplement ("PAS") 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 S. Przybyl, ANI's President and CEO 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."

About Oxcarbazepine tablets

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