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20 Dec 2020
Novartis’ Cholesterol-lowering drug approval denied by US FDA : Daily Current Affairs
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.
