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

Indevus To Market Nebido In The U.S. Upon Approval

This article was originally published in The Pink Sheet Daily

Executive Summary

Indevus expects to file an NDA for the injectable testosterone therapy, licensed from Schering AG, for the treatment of hypogonadism in the second half of 2006.

You may also be interested in...



Endo Gets Surprise Aveed Approval, But REMS Could Be A Roadblock

After seven years of rejection, Endo finally gets FDA’s go-ahead on its long-acting testosterone treatment, but a strict REMS program and plenty of market competitors will make the drug’s launch difficult.

FDA Safety Concerns About Indevus’ Nebido Could Add 24 Months To Approval Timeline

Study to assess safety of hypogonadism therapy's oil-based depot injection could take 18 months.

FDA Safety Concerns About Indevus’ Nebido Could Add 24 Months To Approval Timeline

Study to assess safety of hypogonadism therapy's oil-based depot injection could take 18 months.

Related Content

Topics

UsernamePublicRestriction

Register

PS142351

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

Cancel