April 26, 2024 04:03 (IST)
Aurobindo Pharma receives USFDA approval for drug related to moderate dementia
Hyderabad/Mumbai, Mar 29 (IBNS) Aurobindo Pharma Limited, which manufactures generic pharmaceuticals and active pharmaceutical ingredients, announced on Tuesday that the company has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Rivastigmine Tartrate Capsules USP, 1.5 mg, 3 mg, 4.5 mg and 6 mg.
This product is expected to be launched in the first quarter of fiscal year 2016-17.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Exelon Capsules, 1.5 mg, 3 mg, 4.5 mg and 6 mg, of Novartis Pharmaceuticals Corporation, said the company.
Naproxen Sodium Tablets is used in the treatment of mild moderate dementia of the Alzheimer's and Parkinson's disease.
The approved product has an estimated market size of US$ 26.7 million for the twelve months ending January 2016 according to IMS.
This is the 67th ANDA (including 14 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing oral non-antibiotic products.
Aurobindo now has a total of 246 ANDA approvals (211 Final approvals including 10 from Aurolife Pharma LLC and 35 tentative approvals) from USFDA.
Support Our Journalism
We cannot do without you.. your contribution supports unbiased journalism
IBNS is not driven by any ism- not wokeism, not racism, not skewed secularism, not hyper right-wing or left liberal ideals, nor by any hardline religious beliefs or hyper nationalism. We want to serve you good old objective news, as they are. We do not judge or preach. We let people decide for themselves. We only try to present factual and well-sourced news.
Support objective journalism for a small contribution.
Latest Headlines
Vedanta Ltd Q4FY24 net profit drops 27% YoY to Rs 1,369 cr Thu, Apr 25 2024
Swiggy gets shareholders' nod for $ 1.2 billion IPO Thu, Apr 25 2024
HUL Q4FY24 profit drops 6% YoY to Rs 2,406 cr Thu, Apr 25 2024
Credit card spending grows 27% YoY to Rs 18.26 trillion in FY24: RBI Thu, Apr 25 2024
Mahindra Tractors crosses milestone by selling 40 lakh tractor units Thu, Apr 25 2024
DishTV India expects to touch 30 percent market share at the end of current financial year, says CEO Manoj Dobhal Thu, Apr 25 2024
DCB Bank Q4FY24: PAT grows YoY 9% to Rs 156 cr Wed, Apr 24 2024