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ANI Pharma Reveals Approval And Launch Of Oxycodone Hydrochloride Oral Solution

ANI Pharmaceuticals Inc. (ANIP) announced Friday that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Oxycodone Hydrochloride Oral Solution USP, 100 mg/5 mL (20 mg/mL).

ANI expects to begin shipping to its customers immediately.

Oxycodone Hydrochloride Oral Solution 100 mg/5 mL (20 mg/mL) is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

The current annual U.S. market for this product is approximately $14.5 million, according to IMS Health.

Arthur Przybyl, ANI's President and CEO, said, "We are pleased to announce the launch of our fourth generic product this year. The product was developed internally at ANI and leverages both our liquid manufacturing and controlled substance capabilities."

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