Drug firm Aurobindo Pharma has received final approval from the USFDA to manufacture and market Sevelamer Carbonate tablets in the American market.
The tablets are indicated for control of serum phosphorus in patients with chronic kidney disease on dialysis. "The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture Sevelamer Carbonate tablets 800 mg," Aurobindo Pharma said in a BSE filing today.
This product, a therapeutic equivalent generic version of Genzyme's Renvela tablets, is being launched immediately.
The approved product has an estimated market size of USD 1.9 billion for the 12 months to May 2017, according to IMS.
Aurobindo Pharma has a total of 331 ANDA approvals (294 final nod, including 16 from Aurolife Pharma LLC and 37 tentative approvals) from the US.
(Courtesy: http://www.moneycontrol.com/news/business/aurobindo-pharma-gets-usfda-nod-to-market-kidney-ailment-drug-2329671.html)
Alembic Pharma gets USFDA nod for antihypertensive tablets
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Olmesartan Medoxomil and Amlodipine tablets, Alembic Pharmaceuticals said in a BSE filing.
Drug firm Alembic Pharmaceuticals today said it has received approval from the US health regulator for generic Olmesartan Medoxomil and Amlodipine tablets used for the treatment of hypertension.
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Olmesartan Medoxomil and Amlodipine tablets, Alembic Pharmaceuticals said in a BSE filing.
The approval is for the tablets in the strengths of 20mg/5mg, 40 mg/5 mg, 20 mg/10 mg and 40 mg/10 mg, it added.
The product is generic version of Daiichi Sankyo Inc's Azor tablets in the same strengths, Alembic Pharma said.
The tablets are indicated for the treatment of hypertension, alone or with antihypertensive agents to lower blood pressure, it added.
According to IMS the Olmesartan Medoxomil and Amlodipine tablets had an estimated market size of USD 312 million for twelve months ending December 2016. The company has a total of 61 ANDA approvals from the USFDA.
(Courtesy: http://www.moneycontrol.com/news/business/alembic-pharma-gets-usfda-nod-for-antihypertensive-tablets-2328879.html