Alembic receives USFDA approval for generic Midodrine HCL tablets

Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH).

82
Medicine Tablet
Picture: Pixabay

Alembic Pharmaceuticals Limited 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).


Also read | USFDA, Gujarat FDCA officials share experiences of pandemic


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 US FDA.


The Health Master is now on Telegram. For latest update on health and Pharmaceuticals, subscribe to The Health Master on Telegram.

Follow and connect with us on Facebook and Linkedin

Go to main website, click here

Subscribe for daily free updates, click here

For daily free updates on WhatsApp, click here

Subscribe here for daily updates
Loading

LEAVE A REPLY

Please enter your comment!
Please enter your name here