Research & Development
Amneal wins FDA approval for generic ocular product TobraDex
20 July 2021 -

Pharmaceutical company Amneal Pharmaceuticals Inc (NYSE:AMRX) reported on Monday the receipt of the Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for generic TobraDex (tobramycin/dexamethasone) in 0.3%/0.1% for treating bacterial ocular infection.

With the approval of TobraDex (tobramycin/dexamethasone) in 0.3%/0.1%, the company said it adds another complex ophthalmic product to its generics portfolio.

TobraDex is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists, added the company.

US annual sales for dexamethasone and tobramycin ophthalmic suspension, including the brand TobraDex, for the 12 months ended May 2021 were approximately USD118m, as reported by IQVIA.

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