Product news

Share this article:
The FDA sent an approvable letter to Wyeth seeking more information on the company's menopause treatment Pristiq. In its letter, the FDA said that before Wyeth's Pristiq application could be approved, it would be necessary for the drugmaker to provide additional data regarding the potential for serious adverse cardiovascular and hepatic effects associated with the use of Pristiq as a treatment for moderate-to-severe vasomotor symptoms (hot flashes and night sweats) associated with menopause. The FDA requested that these data come from a randomized, placebo-controlled clinical trial of a duration of one year or more conducted in postmenopausal women.  The agency also requested that Wyeth address certain chemistry, manufacturing and controls deficiencies prior to approval. Wyeth EVP and Chief Medical Officer Gary Stiles said in a statement that the drugmaker will work with the FDA satisfy its requests for additional data and move the medicine forward in the FDA review process.
Share this article:
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Illumina inks deal with J&J, AstraZeneca, Sanofi

The goal is to develop companion diagnostics to match patients with cancer treatments.

Abbott deal highlights inversion inaction

Political furor over the recent spate of tax inversions is having little influence on how the government chooses its partners.

Allergan reported to seek out Salix deal

The Wall Street Journal says the deal would add "another layer of intrigue" to the Allergan-Valeant hostilities.