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

LEDERLE RHEUMATREX (METHOTREXATE) FOR RHEUMOTOID ARTHRITIS will be launched in January in a "specially designed" dose pack. In a Nov. 1 press release announcing FDA approval of the new indication for the oral formulation of the anticancer drug, Lederle said it would be conducting a "comprehensive medical information program" prior to the launch to ensure appropriate use of the drug. FDA approved Lederle's methotrexate for use in treating severe, recalcitrant rheumatoid arthritis on Oct. 31. Lederle had applied for approval of the new indication over three years ago in a supplemental NDA submitted to the agency in June 1985. According to the approved labeling, Rheumatrex is indicated for the "management of selected adults with severe, active classical or definitive rheumatoid arthritis (ARA criteria) who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first line therapy, including full dose NSAIDS (nonsteroidal anti-inflammatory drugs) and usually a trial of at least one or more disease-modifying anti-rheumatic drugs." The off-patent drug will be marketed in a Rheumatrex Dose Pack to differentiate the Lederle product from generics. The Rheumatrex Dose Pack, Lederle said, is "designed to help patients safely comply with specific therapeutic regimen." The recommended dose for the rheumatoid indication is 7.5 mg once a week.

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