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


Alka-Seltzer Plus needs more time to re-label

This article was originally published in The Tan Sheet

Executive Summary

Bayer HealthCare asks FDA for more time to change packaging for its cold and flu relief line to comply with a final rule for labeling acetaminophen products. Thirteen stock-keeping units under the Alka-Seltzer Plus brand will be unable to accommodate organ-specific warnings by the rule's effective date of April 29, Bayer says in a Feb. 16 1letter to the agency. The firm's VP of Regulatory Affairs Leonard Baum explains, "Bayer was forced to wait" for FDA's technical amendment of Nov. 25, 2009, which clarified that smaller immediate containers such as blister cards and sachets must bear liver injury and stomach bleeding warnings (2"The Tan Sheet" Nov. 30, 2009). Bayer asks for a 12-month deferral to re-label ASP foil pouches and stick packs, and a six-month deferral to re-label the companion cartons. A spokeswoman said the company has not yet heard from FDA

You may also be interested in...

FDA Requires Liver Injury Warning On Acetaminophen Stick Packs, Sachets

Acetaminophen products sold in stick packs and sachets must carry warnings about the risk of liver injury by April 29, 2010, a technical amendment to the final rule for internal analgesics says

IIL-Griffith Univ Readying Reasonably Priced COVID-19 Vaccine

The entry of India’s state-owned Indian Immunologicals and partner Griffith University in the COVID-19 vaccine race could potentially disrupt pricing dynamics. The alliance is developing a live-attenuated, single dose vaccine, which it hopes will be ready for launch in 18-24 months.

Cipla Granted Approval For First US Proventil Rival

Shortly after wrapping up a Phase III trial for its proposed generic Advair Diskus product in the US, Cipla has won FDA approval for the first generic Proventil HFA product, as it continues to build up steam in the US respiratory market.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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