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



Executive Summary

GLAXO'S FORTAZ (CEFTAZIDIME) RECIEVED 1-A REVIEW AND CLEARANCE BY FDA, indicating that the agency considers the cephalosporin to be a new chemical entity with an important therapeutic gain over other available drugs, Glaxo said in a July 19 press release announcing approval of the drug. In the press release, Glaxo said that Fortaz is "the first injectable antibiotic to receive FDA's highest ranking in over a decade." Among recent cephalosporin approvals, Hoechst Roussel's Claforan (cefotaxime sodium) and Roche's Rocephin (ceftriaxone) have received 1-B approvals from FDA, indicating a new chemical entity and a modest therapeutic advance. SmithKline's Cefizox (ceftizoxime sodium), Glaxo's Zinacef (cefuroxime sodium), Bristol-Myers' Precef (ceforanide) and Pfizer's Cefobid (cefoperazone sodium) all were classified 1-C drugs, indicating new chemical entities with little or no therapeutic advance. The key therapeutic Significance for Fortaz is its effectiveness in treating severe hospital-acquired infections, Glaxo indicated. The firm maintained that it expects Fortaz "to become the drug of choice in treating a wide variety of hospital-acquired infections," which occur in "an average of 5% of patients admitted to general hospitals." Fortaz is indicated for hospital-acquired pneumonias and urinary tract infections, bacterial septicemia and infections in neutropenic cancer patients, Glaxo said. The company said the injectable drug is also "recommended for use in treating lower respiratory tract infections in cystic fibrosis patients who are particularly susceptible to life-threatening pneumonias caused by haemophilus influenzae, staphylococcus aureus and pseudomonas aeruginosa." Fortaz is also indicated "for the treatment of skin and skin structure infections such as burn wound infections, intra-abdominal infections, bone and joint infections and gram-negative meningitis," the firm noted. Glaxo said the drug will be available in early August. Fortaz will be priced "competitive with other third generation cephalosporins," the company stated. Lilly and SmithKline have both claimed marketing rights to Glaxo's cephalosporin under cross-licensing agreements entered into in 1969. SmithKline said it plans to market the drug next year. Lilly also indicated that it would be filing a Form 6 ANDA with FDA to market the drug. Fortaz is already marketed in 11 foreign countries.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




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