Cobalis Corp.
PreHistin approval process to be conducted by OTC division of U.S. FDA
Published in FDA Law Weekly, February 9th, 2006
Cobalis Corp. (CLSC), a pharmaceutical-development company specializing in antiallergy medications, announced that the company has been notified by the U.S. Food & Drug Administration (FDA) that the marketing approval process (investigational new drug application) for its antiallergy product, PreHistin, will now be conducted within the FDA by the Office of Nonprescription Products, the branch of the FDA which handles over-the-counter (OTC) drug products.
The company sees this as a positive development since, as an FDA-approved OTC drug, PreHistin would not require a doctor's prescription, thus making consumer purchases easier, faster, and more convenient. Based on an...
Want to see the full article?
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of FDA Law Weekly
Source: FDA Law Weekly (2006-02-09)
More Articles from FDA Law Weekly
- Abbott
U.S. FDA grants approval for StarClose vascular closure system - Aperio Technologies
Microscopy systems company hires regulatory affairs executive - Barts & London Queen Mary's School of Medicine & Dentistry
Majority of countries are not fully prepared for an influenza pandemic - Becton Dickinson & Company
U.S. FDA 510(k) grants clearance for infectious disease testing system - BioCryst Pharmaceuticals, Inc.
U.S. FDA grants fast track designation for influenza therapy peramivir - BioDelivery Sciences International, Inc.
IND filed for BEMA LA, a treatment for moderate-to-severe pain - More from this issue of FDA Law Weekly
NewsRx is Social
Follow us on your favorite social network by clicking on a button below:
Top Medical Newsletters
Awards
Best Health/Healthcare Content, 2012
Best Health/Healthcare Content, 2011
Best e-Business Site, 2010
Best e-Business Site, 2009
Best e-Business Site, 2008
Best e-Business Site, 2007
Best e-Business Site, 2006
Best Healthcare Content, 2005
Best Overall Internet Site, 2005
Best Interactive Site, 2005
Facts & Stats
NewsRx also is available at LexisNexis, Gale, ProQuest, Factiva, Dialog, Thomson Reuters, NewsEdge, and Dow Jones.
- Google 2010 PageRank: #2 Among Top Health News and Media Publications
- Google 2010 PageRank: #2 Among Top Science Publications in Biology/Physiology
- Google 2010 PageRank: #2 Among Top News and Media for the Business of Pharmaceuticals
- Amazon's Alexa 2010 PageRank: #2 News and Media Site for the Pharmaceutical Industry
