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news.ANI Pharmaceuticals has received approval from the U.S. Food and Drug Administration (“FDA”) of the Abbreviated New Drug Application (“ANDA”) for Oxycodone HCl Capsules, 5mg.
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Trailing twelve-month sales for the product are $7.5 million according to IMS Health.
ANI president and CEO Arthur S. Przybyl said: "When launched, this will be our third commercial Schedule II narcotic product. In addition, we have received a target action date of January 2, 2017 from the FDA for another Schedule II narcotic product.
"We remain hopeful that we will obtain three additional Schedule II narcotic product approvals within the next 12 months."
About Oxycodone capsules
Oxycodone hydrochloride is an opiod agonist indicated for the management of moderate to severe acute and chronic pain where the use of an opiod analgesic is appropriate.