In Vivo 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

Somerset Emsam Safety Data Should Be Collected To Remove Restrictions

Executive Summary

Somerset should amass safety data on its Emsam (selegiline) patches that would allow FDA to remove dietary restrictions on all strengths of the major depression therapy, the Psychopharmacologic Drugs Advisory Committee said Oct. 26

You may also be interested in...



Bristol Gears Up For Orencia Launch With Creation Of Immunoscience Unit

Bristol-Myers Squibb has created an immunoscience business unit to support the upcoming launch of Orencia (abatacept) for rheumatoid arthritis, U.S. Pharmaceuticals President Anthony Hooper said

Bristol Gears Up For Orencia Launch With Creation Of Immunoscience Unit

Bristol-Myers Squibb has created an immunoscience business unit to support the upcoming launch of Orencia (abatacept) for rheumatoid arthritis, U.S. Pharmaceuticals President Anthony Hooper said

Emsam still in the dark

FDA has extended the user fee date for Somerset's antidepressant patch Emsam (selegiline) by three months to Feb. 26, 2006. The extension will allow FDA to review an amendment the company submitted to the NDA following the Psychopharmacologic Drugs Advisory Committee's October review of Emsam; the committee recommended approval of the monoamine oxidase inhibitor without dietary restrictions for the 20 mg low dose (1"The Pink Sheet" Oct. 31, 2005, p. 5)...

Related Content

Topics

UsernamePublicRestriction

Register

PS046501

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