FDA approves Aurobindo’s Dolophine generic

SILVER SPRING, Md. — Aurobindo Pharma’s received approval from the Food and Drug Administration this week for its generic of Roxane Laboratories’ Dolophine (methadone HCL) tablets. The drug is an opioid intended to manage pain requiring round-the-clock treatment in patients for whom other treatment options are inadequate.

 

Aurobindo’s methadone HCL will be available in 5- and 10-mg tablets. The drug had sales of $61.6 million in the 12 months ended July 2015, according to IMS Health.