Alembic Pharma gets USFDA approval for Moxifloxacin Ophthalmic

Alembic has a cumulative total of 86 ANDA approvals (73 final approvals and 13 tentative approvals) from USFDA, the filing added.

Feb 15, 2019 11:02 IST India Infoline News Service

Alembic Pharmaceuticals
Alembic Pharmaceuticals has received approval from the USFDA for its ANDA Moxifloxacin Ophthalmic Solution USP, 0.5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Vigamox Ophthalmic Solution USP, 0.5%, of Novartis Pharmaceuticals Corporation, the company said in a regulatory filing.

Moxifloxacin Ophthalmic Solution USP, 0.5% has an estimated market size of $68mn for twelve months ending December 2018, according to IQVIA.

Alembic has a cumulative total of 86 ANDA approvals (73 final approvals and 13 tentative approvals) from USFDA, the filing added.

Moxifloxacin Ophthalmic Solution USP, 0.5% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of certain organisms.

Alembic Pharmaceuticals Ltd is currently trading at Rs537 up by Rs1.85 or 0.35% from its previous closing of Rs535.15 on the BSE. The scrip opened at Rs536.65 and has touched a high and low of Rs541.10 and Rs536.65 respectively.

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