Allergy & Immunology
PreHistin approval process to be conducted by OTC division of U.S. FDA
Published in Medical Letter on the CDC and FDA, February 12th, 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 Medical Letter on the CDC and FDA
More Articles from Medical Letter on the CDC and FDA
- Clostridium
Study identified epidemic, toxin gene-variant strain of Clostridium difficile - HIV/AIDS Vaccine
Report outlines behavioral and social issues in HIV vaccine trial in Thailand - Influenza Vaccine
Adverse events are more likely when influenza vaccine is used inconsistent with labeling - Moneypox Risk Factors
Clinical characteristics of human monkeypox are the focus of review - Smallpox Vaccine
Report describes adverse events linked to smallpox vaccine in U.S. - Acute Bacterial Sinusitis
Biopharma company submits NDA for Orapem to treat respiratory tract and skin infections - More from this issue of Medical Letter on the CDC and FDA
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
