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Alembic Pharmaceuticals has received tentative approval from the US Food and Drug Administration (USFDA) for Bimatoprost Ophthalmic Solution, used to treat hypotrichosis of the eyelashes by increasing their growth, including length, thickness and darkness.
The company said it is currently in litigation with Allergan in the District Court of New Jersey and the launch of this product will depend on the outcome of litigation.
The tentatively approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to the reference listed drug product (RLQ), LATISSE ophthalmic solution, 0.03 per cent of Allergan,” Alembic Pharmaceuticals said in a BSE filing today.
Quoting IQVIA sales data, the company said Bimatoprost Ophthalmic Solution had an estimated market size of $63 million for the 12 months ended December 2017. The company said it has 76 ANDA approvals from USFDA.
Shares of Alembic Pharmaceuticals were trading up 1.19 per cent at Rs 599.50 on the BSE.
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