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Amneal Receives Approval for Generic TobraDex

Adding another complex ophthalmic product to the generics portfolio.

Amneal Pharmaceuticals, Inc. today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for the generic version of TobraDex, which adds another complex ophthalmic product to the generics portfolio.

Dexamethasone and Tobramycin Ophthalmic Suspension 0.3%/0.1% is the generic version of TobraDex®, which 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.

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

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According to IQVIA, a leading healthcare data and analytics provider, U.S. annual sales for dexamethasone and tobramycin ophthalmic suspension, including the brand TobraDex for the 12 months ended May 2021 were approximately $118 million.

Important Safety Information for Dexamethasone and Tobramycin Ophthalmic Suspension 0.3%/0.1% includes warning on Intraocular Pressure Increase, Cataracts, Delayed Healing, Bacterial Infections, Viral Infections and Fungal Infections. Reported adverse drug reactions include hypersensitivity and localized ocular toxicity, including eye pain, eyelids pruritus, eyelid edema, and conjunctival hyperemia. See Package Insert (PI) for full prescribing information including complete safety information.

Source: Amneal
Date: Jul 19, 2021


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