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


Regulatory Updates, In Brief

Executive Summary

Labopharm's once-daily trazodone gets regulatory nod: FDA cleared Oleptro, Labopharm's once-daily formulation of the antidepressant trazodone, for treatment of major depressive disorder in adults Feb. 3. Commercialization plans for the extended release tablets appear to rest on when the specialty pharma confirms a marketing partner for the therapy. Labopharm said it is actively exploring alternatives that range from out-licensing to a distribution agreement under which it would retain some degree of co-promotion rights, to a full co-promotion arrangement under which the company would share sales functions with a partner. Labopharm has completed market research with physicians and third-party payers, developed a positioning and marketing campaign and finalized manufacturing and packaging arrangements, so it would appear it is readying Oleptro to be a turn-key opportunity. Oleptro should be available later this year, with a launch to be determined by the final commercialization plan

You may also be interested in...

Tysabri Risk Communication Goes Beyond REMS With Monthly Update For Docs

Biogen Idec's decision to start providing doctors with monthly updates on progressive multifocal leukoencephalopathy cases among Tysabri patients shows the firm's confidence that providing additional risk information will not discourage use of the product

Tysabri Long-Term Users Must Provide Additional Consent In Europe

A three-month EMEA safety review confirms that two years of treatment with the monoclonal antibody increases the risk for PML.

Atypical Antipsychotics To Add Warning About Metabolic Effects In Kids

FDA likely will move metabolic information to the warning section in labeling for all atypical antipsychotics, according to Division of Psychiatry Products Director Thomas Laughren





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