ANI Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Oxycodone Hydrochloride Oral Solution USP, 100 mg/5 mL (20 mg/mL). The current annual U.S. market for this product is approximately $14.5 million, according to IMS Health. ANI expects to begin shipping to its customers immediately.
"We are pleased to announce the launch of our fourth generic product this year,” Arthur S. Przybyl, ANI's President and CEO said. “The product was developed internally at ANI and leverages both our liquid manufacturing and controlled substance capabilities."
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.