Latebreakers: If Mevacor goes OTC, Glaxo will push it
GSK gets OTC marketing rights from Merck for Mevacor
In anticipation of FDA approval, GlaxoSmithKline and Merck have entered into an agreement for OTC marketing rights for lova statin (Mevacor). Under the agreement, Glaxo will have exclusive rights to market nonprescription lovastatin in the United States. Mevacor was introduced in this country in 1987 by Merck as the first in a class of cholesterol-lowering medicines known as statins. The application for OTC lovastatin is scheduled to be reviewed by the FDA on Dec. 13. The application seeks approval of OTC lovastatin 20 mg taken once daily to help lower cholesterol. This is Merck's third application to take lovastatin OTC.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
