FDA clears Amneal’s generic TobraDex

The Food and Drug Administration has approved Amneal’s generic TobraDex (dexamethasone and tobramycin ophthalmic suspension, 0.3%/0.1%). The product is indicated as a treatment for steroid-responsive inflammatory ocular conditions with superficial bacterial ocular infection or risk of a bacterial infection. 

“Today’s announcement of an additional ophthalmic product approval in our generic portfolio is important,” Amneal co-CEOs Chirag Patel and Chintu Patel said in a statement. “It is another proof point of the continued execution of our strategy to develop and commercialize complex generics.”

IQVIA data for the year ended May 2021 showed annual U.S. sales of TobraDex and its generics were $118 million. 

Amneal’s generic will be available in 2.5-ml, 5-ml and 10-ml bottles.