Drugmaker MSN Labs on Thursday said its abbreviated new drug application for a generic version of Cangrelor has received tentative approval from the U.S. Food and Drug Administration (USFDA).
The product will be manufactured at an USFDA and MHRA-approved state-of-the-art injectable facility in Hyderabad, the company said in a release. It is used during percutaneous coronary intervention (PCI) to reduce the risk of blood clots and heart attack.
The USFDA tentative approval comes close on the heels of the company receiving Drugs Controller General of India’s approval for Canreal, its generic version of Cangrelor. “Besides reflecting the capability of MSN Laboratories to deliver products of high-quality standards, this development also provides impetus to our growth aspirations in an important market such as the U.S.,” the company said.
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