FDA approves Akorn's ANDA for generic version of Dilaudid-HP Injection

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Apr 16 2010

Akorn, Inc. (NASDAQ: AKRX) a niche generic pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company's Abbreviated New Drug Application (ANDA) for the generic version of Dilaudid-HP® 10mg/ml Injection. The company intends to begin shipping the product next month.

“These opportunities represent important milestones for our Company and are integral to the execution of our strategy to deliver high value pharmaceuticals.”

In addition, the Company has commenced the manufacturing of Vancomycin HCL for Injection 5gm / vial in its Decatur, IL plant on a contract basis for sale through its joint venture subsidiary, Akorn-Strides. The additional manufacturing site allows the Akorn-Strides joint venture to increase production to meet its current demand for this product.

Raj Rai, the Interim Chief Executive Officer of Akorn stated, "These opportunities represent important milestones for our Company and are integral to the execution of our strategy to deliver high value pharmaceuticals."

According to IMS Health, the U.S. sales for Hydromorphone Hydrochloride Injection 10mg/ml in 1ml, 5ml, and 50ml doses were approximately $28 million in 2009.

SOURCE Akorn, Inc.

Posted in: Pharmaceutical News

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