Latest News | Alembic Pharma Gets USFDA Nod for Low Blood Pressure Treatment Drug
Get latest articles and stories on Latest News at LatestLY. Drug firm Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator for Midodrine Hydrochloride tablets, which are used to treat orthostatic hypotension.
New Delhi, Jan 22 (PTI) Drug firm Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator for Midodrine Hydrochloride tablets, which are used to treat orthostatic hypotension.
The approved product is therapeutically equivalent to the reference listed drug product ProAmatine tablets of Takeda Pharmaceuticals USA, Inc.
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Midodrine Hydrochloride tablets in the strength of 2.5 mg, 5 mg, and 10 mg, Alembic Pharmaceuticals said in a regulatory filing.
Midodrine Hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH).
The drug is used for certain patients who have symptoms of low blood pressure when standing. This condition is also known as orthostatic hypotension.
Quoting IQVIA data, Alembic Pharma said Midodrine Hydrochloride tablets USP 2.5 mg, 5 mg, and 10 mg have an estimated market size of USD 60 million for twelve months ending September 2020.
Alembic now has a total of 138 ANDA approvals (120 final approvals and 18 tentative approvals) from USFDA.
(The above story is verified and authored by Press Trust of India (PTI) staff. PTI, India’s premier news agency, employs more than 400 journalists and 500 stringers to cover almost every district and small town in India.. The views appearing in the above post do not reflect the opinions of LatestLY)