Alembic Pharmaceuticals Limited (Alembic) today announced it has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Midodrine Hydrochloride Tablets USP, 2.5 mg, 5 mg, and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), ProAmatine Tablets, 2.5 mg, 5 mg, and 10 mg, of Takeda Pharmaceuticals USA, Inc. (Takeda). Midodrine Hydrochloride Tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH).
Midodrine Hydrochloride Tablets USP 2.5 mg, 5 mg, and 10 mg have an estimated market size of US$ 60 million for twelve months ending September 2020 according to IQVIA.
Alembic has a cumulative total of 138 ANDA approvals (120 final approvals and 18 tentative approvals) from USFDA.
Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.950.75 as compared to the previous close of Rs. 979.75. The total number of shares traded during the day was 51907 in over 4249 trades.
The stock hit an intraday high of Rs. 992.95 and intraday low of 934.1. The net turnover during the day was Rs. 49345854.