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Daily-current-affairs / 20 Dec 2020

Novartis’ Cholesterol-lowering drug approval denied by US FDA : Daily Current Affairs

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Novartis’ Cholesterol-lowering drug approval denied by US FDA

In News

  • US FDA on 18th December declined the approval of Inclisiran that is a potential treatment for elevated low-density cholesterol in adults.

About

  • The drug was approved by the European commission that was named as Leqvio. This was bought by the Novartis and expects to be a top seller.
  • Approval was denied due to lack of inspection facility issues. Satisfactory resolution is required before it may be approved.
  • Inclisiran is a drug used for the treatment of patients with atherosclerotic cardiovascular disease.

US FDA

  • The US Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.
  • It also ensures the safety of the US food supply, cosmetics, and products that emit radiation.
  • It regulates the manufacturing, marketing, and distribution of tobacco products.
  • It is also responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable.