Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Wyeth Packaging Problems Lead To Warning Letter, Triphasil-28 Recall

Executive Summary

Wyeth failed to adequately investigate cases of contamination involving a packaging extractable for two oral contraceptive drugs manufactured at the firm's Guayama, Puerto Rico facility, FDA states in a recent warning letter

You may also be interested in...



Wyeth Struggling To Avoid Depressed Market For Pristiq

By initially launching its serotonin-norepinephrine reuptake inhibitor Pristiq as a treatment for menopause symptoms, Wyeth may be able to create a niche market for the introduction of its depression indication

Wyeth Struggling To Avoid Depressed Market For Pristiq

By initially launching its serotonin-norepinephrine reuptake inhibitor Pristiq as a treatment for menopause symptoms, Wyeth may be able to create a niche market for the introduction of its depression indication

Biogeneric Bill Has “Reasonable Chance” In ’07 – Barr; More CEOs Unplugged

Barr optimistic about biogenerics in 2007: There is "a reasonable chance for passage" of follow-on biologics legislation in 2007, Barr CEO Bruce Downey says during Morgan Stanley CEOs Unplugged conference in New York Jan. 3. "I would suspect that with the change in the composition of the Congress that we will have hearings on that legislation both in the House and in the Senate," he adds, noting that he expects Rep. Henry Waxman (D-Calif.) to reintroduce follow-on protein legislation during the first two weeks of the new Congress, which was sworn in Jan. 4. Waxman, along with Sens. Chuck Schumer (D-N.Y.) and Hillary Rodham Clinton (D-N.Y.), introduced legislation in October that would grant FDA authority to approve comparable or interchangeable follow-on biologics (1"The Pink Sheet" Oct. 9, 2006, p. 5). If a bill is not passed in 2007, Downey said legislation is unlikely in 2008 due to the presidential election, but he "would certainly expect to see legislation by the end of 2009"...

Related Content

UsernamePublicRestriction

Register

PS047258

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel