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Panacea Biotec says ANDA of Prasugrel approved by US FDA

The company is also entitled for 180 days of shared market exclusivity for the Prasugrel HCL tablets,

Press Trust of India  |  New Delhi 

drugs, medicines, USFDA

Drug firm on Tuesday said it has received final approval from the to launch generic Prasugrel tablets, used for preventing blood clots in people with acute coronary syndrome, in the

The company is also entitled for 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)," said in a BSE filing.

The tablets are generic version of Eli Lilly's Effient tablets, it added.

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, said.

The annual sale of Prasugrel prior to entry of generics in the market was around USD 600 million in the US market, it added.

The tablets are indicated for reduction of thrombotic cardiovascular events in people with acute coronary syndrome.

Shares of were trading 6.74 per cent higher at Rs 255 per scrip on BSE in the afternoon trade today.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

First Published: Tue, October 24 2017. 17:25 IST
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