ANI Pharmaceuticals Inc (NASDAQ:ANIP) Receives FDA Approval for Oxcarbazepine


ANI Pharmaceuticals Inc (NASDAQ:ANIP) shares rose 2.19% to $53.19 on Monday when the company received approval from the U.S. Food and Drug Administration (FDA) for its Oxcarbazepine tablets.

Oxcarbazepine is an antiepileptic drug indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults. It is also used 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.

The FDA approval covers 150mg, 300mg and 600mg doses. IMS Health estimates that the annual market for this product in the U.S. is around $145 million, based on trailing twelve months sales.

ANI Pharmaceuticals is an integrated specialty pharmaceutical company that is engaged in developing, manufacturing and marketing branded and generic prescription pharmaceuticals. It focuses on areas of product development include anti-cancer, hormones and steroids, and complex formulations. Its market cap is $592.66 million at 11.49 million shares outstanding.

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,” said ANI Pharmaceuticals President and CEO Arthur Przybyl in a press statement.

Last month, analysts have set a target of $52 for ANI Pharmaceuticals shares and the recent FDA approval has allowed the stock price to surpass this target. Shares have been trading in a 52-week range of $26.80 to $73.54 so there’s significant room to go if there’s further upside momentum.

As of the latest reporting period, ANI Pharmaceuticals has an EPS of $1.06 and analysts predict that it can pick up by 31.58% for the next year and 15.00% for the next five years. The company’s P/E ratio growth currently stands at 3.26.


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