ANI gets FDA OK for generic Trileptal, launches 5-mg oxycodone

BAUDETTE, Minn. — ANI Pharmaceuticals on Monday announced the approval of one drug and the launch of another. The company announced that it had received FDA approval for its generic Trileptal (oxcarbazepine) tablets.

 

The drug will be available from ANI in 150-, 300- and 600-mg dosage strengths, and it saw annual sales of $145 million, according to IMS Health. It is indicated as a monotherapy or adjunctive therapy to treat partial seizures in adults and as monotherapy in the treatment of partial seizures among children with epilepsy 4 years of age and older. It can also be used as an adjunctive therapy in children older than 2 years of age with partial seizures. The company said this approval is part of its efforts to re-activate discontinued abbreviated new drug applications that it has acquired in recent years. 

 

ANI on Monday also introduced its 5-mg oxycodone tablets, which IMS Health says saw $7.5 million in trailing 12-month sales. The drug is indicated to manage moderate to severe acute and chronic pain in patients for whom opioid therapy is deemed appropriate. 

 

“We are excited to add our third Schedule II narcotic product to our commercial portfolio,” ANI president and CEO Arthur S. Przybyl said. “This is ANI's sixth new product introduction in the second quarter of 2016.”