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

Approvals In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Genentech Avastin lung cancer claim clears FDA, while Merck’s new molecular entity Zolinza (vorinostat) is approved for cutaneous T-cell lymphoma. Schering-Plough’s novel antifungal Noxafil (posaconazole) is the first treatment cleared for prevention of invasive Aspergillus infection. Genentech/Biogen Idec’s Rituxan (rituximab) gains a third NHL-related claim with approval of two new indications; Johnson & Johnson’s established anti-TNF agent Remicade (infliximab) expands into the dermatology segment with approval for psoriasis. More approvals in brief

You may also be interested in...



FDA Offers Possible Reasons For Vectibix Failure To Show Survival Benefit

FDA review documents for Amgen's epidermal growth factor receptor inhibitor Vectibix (panitumumab) outline possible factors that may have led to the biologic's failure to show an overall survival benefit in a pivotal trial.

Berlex Yaz gains acne claim

Berlex's oral contraceptive Yaz (drospirenone/ethinyl estradiol) clears FDA Jan. 26 for the treatment of moderate acne vulgaris in women who desire an oral contraceptive for birth control. Based on two six-month trials in more than 1,000 patients, the oral contraceptive showed significant reduction in inflammatory and noninflammatory lesion counts. The approval marks the third indication for Yaz, which is also indicated for treatment of emotional and physical symptoms of premenstrual dysphoric disorder (1Pharmaceutical Approvals Monthly October 2006, p. 5)...

Approvals In Brief

Exubera is first inhaled insulin: Pfizer's inhaled insulin Exubera - the first of its kind - is not meant as a replacement for injectable insulins, even though it allows recipients to reach peak insulin concentrations more quickly, FDA Center for Drug Evaluation & Research Director Steven Galson emphasizes in announcing approval Jan. 27. Pfizer plans to launch the product by summer. Exubera, a short-acting insulin, is indicated for "the treatment of adult patients with diabetes mellitus for the control of hyperglycemia." In patients with type 1 diabetes, Exubera should be used with longer-acting insulin. In patients with type 2 diabetes, Exubera can be used as monotherapy or in combination with oral agents or longer-acting insulins, labeling states. A recommendation for patients to get lung function tests every six to 12 months will continue until the agency has more information on Exubera's effect on the lungs from post-marketing studies. Pfizer acquired Sanofi-Aventis' marketing rights to Exubera for $1.3 bil. in January, building on the firms' previous co-development alliance (1Pharmaceutical Approvals Monthly January 2006, p. 42)...

Topics

UsernamePublicRestriction

Register

OM007016

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