Alembic Pharma Announces USFDA Approval for Moxifloxacin Ophthalmic Solution

Alembic Pharmaceuticals Limited (Alembic) announced it has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Moxifloxacin Ophthalmic Solution USP, 0.5 percent. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Vigamox Ophthalmic Solution USP, 0.5 percent, of Novartis Pharmaceuticals Corporation. Moxifloxacin Ophthalmic Solution USP, 0.5 percent is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of certain organisms. Moxifloxacin Ophthalmic Solution USP, 0.5 percent has an estimated market size of USD 68 million 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. – Medical Buyer Bureau