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


New cholesterol combo

Executive Summary

Kos' Advicor (niacin/lovastatin) combination receives "approvable" letter from FDA July 20 after a 10-month review. Kos is seeking an indication for treatment of primary hypercholesteremia and mixed dyslipidemia for patients requiring more lipid modification than either of the components alone. Full approval awaits expiration of the six-month pediatric exclusivity granted to Merck's Mevacor (lovastatin), which expires Dec. 15, as well as completion of FDA's inspection of Miami-based Kos' manufacturing facility

You may also be interested in...

Kos Advicor Will Launch in Feb.; Lovastatin Pediatric Exclusivity Expires

Kos' combination cholesterol drug Advicor will launch in February following its Dec. 17 approval

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011



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