ANI Pharma: FDA Approves Oxycodone Hydrochloride Oral Solution 5mg/5mL

(RTTNews) - ANI Pharmaceuticals, Inc. (ANIP) announced that it has received approval from the U.S. Food and Drug Administration or FDA of its Abbreviated New Drug Application or ANDA for Oxycodone Hydrochloride Oral Solution 5mg/5mL. Trailing twelve-month sales for the product are $30 million, according to IMS, with three current competitors.

ANI said it expects to begin shipping to its customers shortly.

ANI has forty-six generic drug products under development addressing a total annual market size of approximately , based on data from IMS Health.

Giving a brief description on Oxycodone Hydrochloride Oral Solution 5mg/5mL, the company said it is an opioid agonist indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.