Smokers' drug granted fast-track status
The FDA has granted fast-track status to Champix (varenicline), Pfizer's experimental smoking-cessation treatment. The company says the drug helps smokers quit by reducing the severity of cravings and withdrawal symptoms. If the review process begins in January 2006 as expected, approval to begin marketing the product could be granted by July. If approved, the drug is expected to compete with Sanofi-Aventis' Acomplia (rimonabant), which was developed originally for obesity but has been found to be effective in aiding smoking cessation as well.
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.
