Companies

Alembic Pharma gets USFDA nod for ophthalmic solution

PTI | Updated on February 15, 2019 Published on February 15, 2019

New Delhi, Feb 15 (PTI) Drug firm Alembic Pharmaceuticals Friday said it has received approval from the US health regulator for Moxifloxacin Ophthalmic Solution, used for treatment of bacterial conjunctivitis caused by susceptible strains of certain organisms.

The approved product is therapeutically equivalent to the reference listed drug product Vigamox Ophthalmic Solution USP, 0.5 per cent, of Novartis Pharmaceuticals Corporation.

“The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Moxifloxacin Ophthalmic Solution USP, 0.5 per cent,” Alembic Pharmaceuticals said in a BSE filing.

Quoting IQVIA sales data, the company said, Moxifloxacin Ophthalmic Solution USP, 0.5 per cent, has an estimated market size of USD 68 million for 12 months, ending December 2018.

The company said it now has a total of 86 ANDA approvals from the USFDA.

Published on February 15, 2019
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