Alembic Pharmaceuticals Limited has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Azelastine Hydrochloride Ophthalmic Solution, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Optivar Ophthalmic Solution, 0.05%, of Mylan Specialty L.P. (Mylan). Azelastine Hydrochloride Ophthalmic Solution 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
Azelastine Hydrochloride Ophthalmic Solution, 0.05%, has an estimated market size of US$ 8.5 million for twelve months ending December 2018 according to IQVIA.
Alembic now has a total of 89 ANDA approvals (76 final approvals and 13 tentative approvals) from USFDA.
Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.542 as compared to the previous close of Rs. 540.15. The total number of shares traded during the day was 1278 in over 64 trades.
The stock hit an intraday high of Rs. 542.35 and intraday low of 536. The net turnover during the day was Rs. 689181.