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


Approvals In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Aptivus clears FDA for HIV: Labeling for Boehringer Ingelheim's HIV agent Aptivus (tipranavir) advocates use of genotypic or phenotypic testing and/or treatment history to help guide therapy. The non-peptidic protease inhibitor received accelerated approval June 22 for use with Abbott's Norvir (ritonavir) for "treatment of HIV-1 infected adult patients with evidence of viral replication, who are highly treatment-experienced or have HIV-1 strains resistant to multiple protease inhibitors." Accelerated approval was based on response rate in two 24-week, open-label Phase III trials; to support full approval, BI will submit 48-week data from two ongoing Phase III studies by Sept. 30, 2006. Postmarketing studies will look at therapeutic drug monitoring and drug-drug interactions. Like other protease inhibitors, Aptivus has an extensive interaction profile: it is either contraindicated or "not recommended" for concomitant use with 19 drugs...

You may also be interested in...

NitroMed’s BiDil XR Will Use Elan Delivery Technology Under Recent Deal

NitroMed aims to have a regulatory and development plan for an extended-release formulation of its heart failure combo therapy BiDil (isosorbide dinitrate/hydralazine) by the middle of the year, the firm told Pharmaceutical Approvals Monthly

Exubera clarification

Pfizer's inhaled insulin product Exubera is not a new molecular entity, according to FDA. Prior to the agent's January approval, the sponsor had referred to Exubera as a "new chemical compound" in filings with the Securities & Exchange Commission. Exubera "is native sequence human insulin and therefore is not technically an NME," according to FDA's Office of Drug Evaluation II. "The insulins that are NMEs…have different amino acid sequences," FDA explains. The most recently approved NME insulin is Novo Nordisk's Levemir (insulin detemir), approved in June 2005 (1Pharmaceutical Approvals Monthly July 2005, p. 15); prior to that, Sanofi-Aventis' Apidra (insulin glulisine) was cleared as an NME in April 2004. Exubera is the first inhaled insulin to clear FDA...

QLT Eligard Sales Suspended For Two Months; Aczone Could Launch In 2007

U.S. sales of QLT/Sanofi-Aventis' Eligard will be suspended for two months due to a patent dispute with rival leuprolide implant Lupron marketer TAP, despite a court ruling that allows for sales to continue

Related Content





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