Please login to the form below

Not currently logged in
Email:
Password:

Jazz submits complete responses for Luvox CR to FDA

US-based Jazz Pharmaceuticals, has said that the FDA accepted for review the NDA submission of the complete response by Solvay for its neurology treatment, Luvox CR (fluvoxamine) extended-release capsules.

US-based Jazz Pharmaceuticals, has said that the FDA accepted for review the NDA submission of the complete response by Solvay for its neurology treatment, Luvox CR (fluvoxamine) extended-release capsules.

The PDUFA action date is 22 December 2007.

The NDA for Luvox CR seeks marketing approval for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) and the treatment of social anxiety disorder (SAD).

The FDA has also accepted the submission of the complete response by Solvay Pharmaceuticals to the FDA approvable letter for Luvox (fluvoxamine) standard tablets. The PDUFA action date is 21 December 2007.

In January 2007, Jazz Pharmaceuticals licensed US marketing rights for Luvox CR and Luvox from Solvay Pharmaceuticals. Solvay retains the right to market both products in other territories around the world.

Subject to receipt of FDA approval, Jazz says it will launch Luvox CR in the US in Q1 2008.

Lehman Brothers say that Luvox CR sales should reach USD 170m in 2011 and USD 230m by 2015.

6th August 2007

Share

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
bmore group

OUR PROMISE: BETTER HEALTH FROM TRIAL TO TREATMENT.We are a full service, independent network of specialist agencies under one roof....

Latest intelligence

Planning your clinical trial? Why you need to engage patients sooner
It’s highly likely that clinical studies are deterring patients based on decisions made in the early stages, such as during planning and design....
Patient-centricity in improving patient recruitment advertising
This blog looks into the importance of concepts and patient centricity in patient recruitment....
AI and life sciences
AI: the smart money is on the smart thinking
Looking at the three key areas where AI is being applied: drug discovery, clinical decision-making and clinical trials...

Infographics