Pink Sheet is part of the Business Intelligence Division 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

GENERIC DIAZEPAM APPROVALS WILL GET HHS PUBLICITY BOOST

Executive Summary

GENERIC DIAZEPAM APPROVALS WILL GET HHS PUBLICITY BOOST through a press conference scheduled by the dept. for Sept. 2 HHS notified news organizations that the press conference would be held to discuss a "big generic drug approval," presumably the first set of ANDA clearances for generic versions of Roche's Valium. The press conference will be conducted by HHS Secty. Heckler. Although it has previously issued press releases upon the approval of initial generic versions of major post-1962 drugs, HHS has not set up a full press briefing to announce such an approval. However, the high consumer recognition of the Valium tradename gives it symbolic value which is unusual for an Rx product. The approval of generic versions of such a highly visible branded drug gives the administration an opportunity to highlight the action in terms of cost savings for consumers. Roche may also be considering a lawsuit to forestall generic marketing of diazepam. The firm still has a petition pending at FDA to require that generic mfrs. of diazepam perform further studies before they are approved for marketing.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS008861

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

Cancel