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

FDA approves new strength of Omnitrope

Executive Summary

FDA approves Sandoz's sNDA for a new strength cartridge (10 mg/1.5 mL) of Omnitrope's liquid formulation for use with a new reusable injector pen, Omnitrope Pen 10. The injector pen formulation of the follow-on human growth hormone, modeled after Pfizer's Genotropin, was first approved in January in a 5 mg strength (1"The Pink Sheet," Jan. 28, 2008, p. 10). Critics at first lambasted the delivery system, pointing out the difficulty in giving children daily injections. Sandoz says that the 10 mg version will offer more extensive dosing options because the cartridge needs to be refilled less often, providing doctors more flexibility with treatment options

Related Content

UsernamePublicRestriction

Register

PS050066

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