Alembic receives tentative USFDA nod for Bimatoprost Ophthalmic Solution

Alembic Pharmaceuticals has received a tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bimatoprost Ophthalmic Solution, 0.03 per cent.

The Bimatoprost Ophthalmic Solution, 0.03 per cent is indicated for the treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.

The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLQ), LATISSE ophthalmic solution of Allergan. The solution has an estimated market size of US$ 63 million for 12 months ending December 2017, according to IQVIA.

On Monday, the shares of Alembic Pharmaceuticals increased by over 2 per cent. The shares of Alembic hit an intraday high of Rs. 613 per share and an intraday low of Rs. 592 per share on the BSE. Its 52-week high was Rs. 613 per share and 52-week low was Rs. 412 per share on the BSE.

At 01:59 hours, Alembic pharma was quoting Rs. 601 per share, up by 1.53 per cent while the Indian Benchmark Indices, Nifty50 was quoting 11,399 level up by 0.34 per cent or 38.80 points and BSE Sensex traded at 37,734 level up by 179 points or 0.48 per cent.