Alembic Pharmaceuticals receives USFDA approval for Tobramycin Ophthalmic Solution USP

Alembic Pharmaceuticals announced that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tobramycin Ophthalmic Solution USP, 0.3%. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Tobrex Ophthalmic Solution, 0.3%, of Novartis Pharmaceuticals Corporation. Tobramycin Ophthalmic Solution USP, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria.

Tobramycin Ophthalmic Solution USP, 0.3% have an estimated market size of US$ 9.6 million for twelve months ending December 2018 according to IQVIA.

Alembic now has a total of 92 ANDA approvals (80 final approvals and 12 tentative approvals) from USFDA.

 

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