FDA decision on WC 3016 anticipated tomorrow (NASDAQ:WCRX)

By John McCalister on 01/25/2010 – 11:56 am PSTLeave a Comment

WC 3016 is a type of oral contraceptive (of low dose) that is being developed by Warner Chilcott Ltd. (NASDAQ: WCRX). This drug is used by women for birth control. Since it is still in its development phase, it is not sold in the market yet. The affiliate of the company, Warner Chilcott Company Inc., has already submitted the application – the New Drug Application (NDA) – to the United States of America’s Food & Drug Administration for the approval to market WC 3016. The submission was made on March 26, 2009. Upon receiving the application, the FDA has given the company a Prescription Drug User Fee Act date (also called Action date or just PDUFA date). This is the date on which the Food & Drug Administration must respond to Warner Chilcott’s application for marketing approval of WC 3016. The PDUFA date is usually 10 months away from the date the FDA “files the new drug application for standard review”. As a result, Warner Chilcott announced on May 26, 2009 that the anticipated PDUFA date for WC 3016 is January 26, 2010.

The New Drug Application (NDA) is the means through which drug companies, like Warner Chilcott Ltd., formally propose that the Food & Drug Administration approve a new pharmaceutical drug for sale and marketing in the United States.
In case of WC 3016, the main use of the submitted NDA is to give sufficient information on the drug to allow the FDA to understand and decide:

Whether the benefits of using WC 3016 in birth control are greater than the risks associated.

Whether the drug WC 3016 is effective and safe if used by women for birth control.

Whether the labeling and the packaging of the drug that Warner Chilcott has planned is suitable.

Whether the packaging should contain other information about WC 3016.

Whether the techniques that have been used to manufacture the drug WC 3016 are proper.

Whether the controls that have been used by Warner Chilcott are enough to protect the quality, purity, strength and identity of WC 3016.

Warner Chilcott is one of the leading specialty pharmaceutical companies (of medium size) that are operating in the United States of America. It develops, manufactures, markets and then sells branded pharmaceutical products. It only sells prescription drugs (not over-the-counter ones). Also, the company develops and markets drugs for women only. The main areas it focuses on are healthcare and dermatology.

The company prides itself on its specialty sales force that is made up of more than 400 representatives. Warner Chilcott’s extraordinary marketing strategies have enabled it to build profitable and high-growth franchises in its two core areas (that is, healthcare and dermatology). According to the company, their “proven product development capabilities” and their “ability to execute acquisitions and in-licensing transactions and develop partnerships” have been the reasons for the profits and growth of their franchises.

A few of the popular drugs under its pipeline are Actonel^®, Asacol^®, Didronel^®, Doryx^®, Enablex^®, femhrt^®, Femcon^® Fe, Loestrin^® 24 Fe, Macrobid^®, Macrodantin^®, Ovcon^® 50, and Sarafem^®.