FDA Approves Amneal’s Generic Version of TobraDex

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Amneal Pharmaceuticals received ANDA approval from FDA for the generic version of TobraDex.

Amneal Pharmaceuticals announced on July 19, 2021 that it received abbreviated new drug application approval from FDA for the generic version of TobraDex.

Dexamethasone and tobramycin ophthalmic suspension 0.3%/0.1% is the generic version of TobraDex and is indicated for steroid-responsive inflammatory ocular conditions. Specifically, when a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

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


Source: Amneal Pharmaceuticals