US FDA refuses to approve GSK's HIV drug


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▴ GSK
In complete response letter from the FDA regulator questioned the treatment's chemistry, manufacturing and controls process

British drug maker ,Viiv, a divison of GSK for AIDS medicine reported denial of US FDA for it's long acting HIV injection. The company said ,complete response letter (CRL) from the FDA in questioned the treatment’s chemistry, manufacturing and controls process but not its safety.

The long acting injection was meant to replace the daily AIDS drugs and company is determined to work with FDA to overcome their concerns.The injection has  proven to be as effective as standard daily pills with three active ingredients when taken monthly and also once every two months.

US drugmaker Gilead Sciences is the market leader of HIV drugs with it's drug Biktarvy, which was approved last year.

Tags : #usfdadenial #gsk #aidsdrug #manufacturing #drug #medicircle

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