Amneal Receives Approval for Generic TobraDex

Dexamethasone and Tobramycin Ophthalmic Suspension is the generic version of TobraDex, which is indicated for steroid-responsive inflammatory ocular conditions

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) 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.

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.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.

Amneal has an extensive portfolio of approximately 250 product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system and endocrine disorders.

The Company also owns 65% of AvKARE. AvKARE provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing. For more information, visit www.amneal.com.

SOURCE: Amneal Pharmaceuticals