ANI gets FDA approval for oxycodone, launches hydrocortisone rectal cream

SILVER SPRING, Md. and BAUDETTE, Minn. — ANI Pharmaceuticals on Tuesday announced the Food and Drug Administration approval for one new generic and the launch of another. 

 

The company received FDA approval for its generic of oxycodone HCl capsules. The drug will be available in 5-mg dosage strength, and it saw annual sales of $7.5 million for the 12 months ended February 2016, according to IMS Health. The drug is indicated to manage moderate to severe acute and chronic pain when opioid use is appropriate. 

 

“When launched, this will be our third commercial Schedule II narcotic product,” ANI president and CEO Arthur Przybyl said. “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.”

 

The company also announced the launch of its hydrocortisone retal cream 1% and 2.5%. The cream is indicated for relief of corticosteroid dermatoses. The two products saw annual sales of about $84 million for the 12 months ended February 2016, according to IMS Health. 

 

“We are excited to add these niche topical products to our growing generic portfolio,” Przybyl said.