Tuesday, Mar 19 2024 | Time 15:20 Hrs(IST)
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Business Economy


Panacea Biotec gets USFDA nod to launch Prasugrel tablets

Mumbai, Oct 24(UNI)Pharma Major, Panacea Biotec today said it has received final approval from the US health regulator to launch generic Prasugrel tablets,
Prasugrel tablets are used for preventing blood clots in people with acute coronary syndrome, in the American market.
The company is also entitled to 180 days of shared market exclusivity for the Prasugrel HCL tablets, it added.
''The company’s first-to-file abbreviated new drug application (ANDA) of Prasugrel 5 mg and 10 mg tablets has been approved by the US Food and Drug Administration (USFDA),'' company said in a filing with BSE.
The tablets are a generic version of Eli Lilly’s Effient tablets, it added.
Panacea Biotec Joint MD Rajesh Jain said ''Approval and launch of this first to file ANDA product is an important milestone to achieve growth in our US business.''
The product has been launched in the market by Apotex Corp, which is the exclusive sales and distribution partner for this product in US, Panacea Biotec said.
The annual sale of Prasugrel prior tothe entry of generics in the market was around USD600 million in the US market, it added.
UNI JS NP1625
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