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

Novartis apologizes for slow reporting

Novartis is apologizing to Japan after the Ministry of Health, Labor and Welfare said the company had dragged its feet reporting adverse events for two of its cancer drugs.

J&J pulls morcellator from market

The company is calling the move a withdrawal, as opposed to a recall.

Pfizer buys two Baxter vaccines

The meningitis and encephalitis medications earned a combined $300 million last year.