June 30, 2026 05:32 am (IST)
Follow us:
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
From Mumbai teen to AI trailblazer: Meet 19-year-old Dhravya Shah behind Supermemory's $3 million funding
Mon, Jun 29 2026
Stop exchanging currency! You can use UPI app in Seychelles in future. List of other nations where the app can be used
Mon, Jun 29 2026
Why did Kotak Mahindra Bank stock fall 3% today? CEO Ashok Vaswani's decision explained
Mon, Jun 29 2026
India overtakes Taiwan, South Korea to become world's fifth-largest equity market again
Mon, Jun 29 2026
Best Car Insurance for Cars Driven Less Than 5,000 KM a Year
Sat, Jun 27 2026