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

Lilly ICOS Cialis EU approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Lilly ICOS' erectile dysfunction therapy Cialis (tadalafil) receives EU marketing approval Nov. 12 based on data package including 1,112 men in Phase III studies. Lilly projects U.S. approval in second half of 2003; FDA requested additional clinical pharmacological studies in an April 29 "approvable" letter. The firm says the Carolina, Puerto Rico facility where the U.S. product will be manufactured recently received a successful FDA inspectio

You may also be interested in...



The Top Five (Non-COVID) Pharma Stories Of 2020

The (virtual) doors closing on the J.P. Morgan Healthcare Conference is the sign for the biopharma industry that the new year has truly started, but before we get too far into 2021, Scrip has taken a look at five of the biggest non-COVID-19 story themes of 2020 in no particular order.

The Race To Vaccinate The World Against COVID-19

Our graphic tracker of key developments from emergency authorized vaccines, the global roll-out, and late-stage vaccine candidates.

China Rings In New Year With Major Deals, Record IPOs And Trends To Watch

From bringing innovative new drugs to global markets, to record-setting fundraisings and initial public offerings, five trends are emerging in China's health sector that are worth closely watching in 2021.

Topics

UsernamePublicRestriction

Register

OM006665

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