Alembic gets USFDA nod for Midodrine Hydrochloride Tablets

Drug manufacturer, Alembic Pharmaceuticals informed the exchanges on Friday that it had secured approval from the United States Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Midodrine Hydrochloride Tablets USP, 2.5 mg, 5 mg, and 10 mg. 

The abovementioned drug is used for the treatment of symptomatic orthostatic hypotension and is therapeutically equivalent to the reference listed drug product (RLD), ProAmatine Tablets, 2.5 mg, 5 mg, and 10 mg, of Takeda Pharmaceuticals.  

According to data from IMS Health (IQVIA), Midodrine Hydrochloride Tablets USP in strengths of 2.5 mg, 5 mg, and 10 mg, have an estimated market size of around US$ 60 million for twelve months ending September 2020.  

Meanwhile, the company’s December quarter performance saw a decline in US sales of 1 per cent, compared to 33 per cent growth registered during the first half of the year. Market sentiment has been impacted recently, with the stock correcting by more than 9.46 per cent since the start of CY 2021.  

On Wednesday, the stock of Alembic Pharmaceuticals closed at Rs 940.65 per share, down by 1.06 per cent or 10.10 per share. The 52-week high is  Rs 1,150 while the 52-week low is Rs 436.10 on BSE.