Live
- Amazon India to Relocate Bengaluru HQ for Cost Efficiency
- Sringeri seer performs bhumi puja for Galigopuram construction
- Russia Launches Major Attack on Ukraine: 8 Dead, Energy Infrastructure Targeted
- Agency villages to get facelift under PM JANMAN scheme
- GITAM students excel in campus recruitment drive
- Sushmita Sen emphasises the power of action over intention
- Eating eggs could help boost memory in women, new study finds
- Youth booked under PD Act, shifted to prison
- Man’s Guide to Self-Care: The Ultimate Grooming Gift Guide for International Men’s Day
- ATP Finals: Jannik Sinner becomes first Italian to win Finals; season-ending event to be played in Italy till 2030
Aurobindo gets FDA nod for dementia drug
City-based Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Rivastigmine Tartrate Capsules, indicated for the treatment of mild moderate dementia, in the American market.
Hyderabad: City-based Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Rivastigmine Tartrate Capsules, indicated for the treatment of mild moderate dementia, in the American market.
The company is gearing up to launch the product in the first quarter of next fiscal (FY17). “Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the USFDA to manufacture and market Rivastigmine Tartrate Capsules USP, 1.5 mg, 3 mg, 4.5 mg and 6 mg,” the drug maker said in a release.
The approved drug is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Exelon Capsules of Novartis Pharmaceuticals Corporation. The capsules are 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 $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 for manufacturing oral non-antibiotic products. Aurobindo now has a total of 246 ANDA approvals from USFDA.
