Somaxon may delay Silenor filing

Somaxon announced yesterday it will delay filing the NDA for Silenor until the first quarter of 2008. The company received a letter from the FDA stating the company must include transgenic mouse carcinogenicity data from an ongoing study. The agency wants Somaxon to provide the data in order to assess whether the sleeping drug could cause cancer. The company had originally planned to include the data after the NDA had been filed.

- see this release for more

Related Articles:
Somaxon touts latest Phase III results for Silenor. Report
Somaxon touts mid-stage data on smoking cessation. Report
Somaxon unveils $86.2M IPO. Report

Suggested Articles

Bausch Health is paying $10 million upfront for the option to acquire Allegro Ophthalmics’ eye disease assets, with a promise of $40 million to come.

Anthony Coyle, Ph.D., has signed up to run Repertoire Immune Medicines’ R&D.

The IPO haul will set Kronos up to start a registrational phase 2/3 trial of a first-line AML drug licensed from Bischofberger's former employer.