Amneal Pharmaceuticals Inc (NYSE: AMRX), a fully integrated pharma firm that concentrates on the distribution, manufacturing, and development of specialty and generic drug products, recently announced that it had managed to receive ANDA (Abbreviated New Drug Application) approval from the FDA for its generic TobraDex drug, which is the addition of another complicated ophthalmic drug products to the company’s generics portfolio.
Amneal has a comprehensive portfolio that comprises about 250 product categories. In addition, it’s expanding its drug product portfolio to include complicated dosage forms, such as biosimilars, in a wide variety of therapeutic areas. Amneal also has branded pharma products via its Specialty sector that focuses primarily on endocrine and nervous system disorders.
The TobraDex Version
Tobramycin and Dexamethasone Ophthalmic Suspension 0.1$/0.3% id TobraDex’s generic version. It is meant for inflammatory steroid-responsive ocular conditions and disorders for which corticosteroids are indicated. Also, where there’s an existing risk of getting a bacterial ocular infection or where there’s a superficial bacterial ocular infection.
Co-Chief Executive Officers of the company, Chintu and Chirag Patel, said how vital another ophthalmic product approval was for the company. They said that it’s another piece of evidence showing how they’re continuing to execute their strategy to commercialize and develop complex generics.
According to a leading healthcare analytics and data provider, IQVIA, United States annual sales for tobramycin and dexamethasone ophthalmic suspensions, including the TobraDex brand, was roughly $118 million year ended May 2021.
Amneal also owns about 65% of AvKARE, a company that provides surgical, medical, and pharma products and services to mostly government agencies, focusing primarily on the Department of Veterans Affairs and the Department of Defense. This company is also both a wholesale distributor and packager of vitamins and pharmaceuticals to its institutional and retail customers in the U.S.
Important safety data for Tobramycin and Dexamethasone Ophthalmic Suspension includes warnings on Fungal infections, Viral Infections, Bacterial Infections, Delayed Healing, Cataracts, and Intraocular Pressure Increase. The adverse drug reactions that have been recorded include localized ocular toxicity and hypersensitivity. This included conjunctival hyperemia, eyelid edema, eyelids pruritus, and eye pain.