NPPA Allows Abbott to Withdraw Dissolvable Stent from India

The National Pharmaceutical Pricing Authority (NPPA) yesterday allowed US drug manufacturer Abbott to withdraw its bioresorbable vascular scaffold brands ‘Absorb’ and ‘Absorb GT1’ due to safety concerns.

NPPA said that it took note of concerns raised by USFDA, EU, TGA-Government of Australia and Indian bodies on enhanced adverse cardiac activity including increased level of thrombosis in case of these stents.

NPPA said that it has allowed immediate withdrawal of Absorb and Absorb GT1 brands of coronary stents of Abbott under exceptional circumstances in public interest. Safety concerns was the prime reason cited by the authority for the permission to withdraw.

NPPA also directed the company to continue to follow-up implanted patients in existing Absorb clinical trials and attend to all follow-up issues arising in the cases under trial and others who have got the device implanted in india in the same manner that the company has been asked to do by US and EU drug regulators.

The company will also have to issue public notice in newspapers and company website in order to formally complete the process of withdrawal.



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