- Oxytrol for Women Now OTC. // Monthly Prescribing Reference;Mar2013, Vol. 29 Issue 3, pA-13
The article informs that U.S. Food & Drug Administration (FDA) has approved drug Oxytrol for women, the first over-the-counter (OTC) treatment for overactive bladder in women.
- OTC. // Drug Topics;10/6/2003, Vol. 147 Issue 19, p116
Features various over-the-counter drugs approved by the U.S. Food and Drug Administration as of October 2003. PrimaVu Herbal Eye Drops from Prima Vu Health Care; Sierra Medicinals' Dr. Steven Rosenblatt's Starch Blocker.
- Q & A Future of OTC. // Drug Store News;3/17/2014, Vol. 36 Issue 3, p22
The article presents questions and answers related to over-the-counter (OTC) drugs in the U.S., the progress in making OTCs eligible for the U.S. Food and Drug Administration and the key opportunities for the OTC industry.
- Sanofi-aventis' Allegra to Go O-T-C. // MMR;2/7/2011, Vol. 28 Issue 3, p16
The article reports about the U.S. Food and Drug Administration's approval of an allergy medication Allegra-D for over-the-counter use.
- Mevacor's OTC switch draws mixed views. // Drug Topics;1/24/2005, Vol. 149 Issue 2, p4
This article reports on the mixed views concerning the issue of whether the U.S. Food and Drug Administration should approve the lovastatin drug Mevacor from Merck & Co. Inc. as an over-the-counter drug.
- The Importance of FDA Approval Packages and Briefing Documents in Pharmacy Education. Sasich, Larry D.; Sukkari, Sana R.; Cook, G. Elliott; Tuttle, Donald A. // American Journal of Pharmaceutical Education;Jul2011, Vol. 75 Issue 7, p1
A letter to the editor is presented in response to the article that underscores the significance of the U.S. Food and Drug Administration (FDA) approval documents in conducting independent evaluations on the therapeutic values of new drugs.
- Regulatory Regime. // U.S. Pharma & Healthcare Report;Q1 2012, Issue 1, p15
The article discusses the regulatory regime of the U.S. Food and Drug Administration (FDA). The primary tasks of the FDA include product approvals, labelling and ensuring high manufacturing standards, providing manufacturing establishment licenses and ensuring safety of the blood supply. The...
- The Case for Leaving the 510(k) Argument Out of a Pleading. O'Reilly, Jim // Products Liability;Summer2013, Vol. 24 Issue 2, p16
The article presents a history of the 1976 Medical Device Amendments as a background to the 510(k) regulatory approval process of the U.S. Food and Drug Administration. The author narrates his experience as a drafter in the writing and adopting classification standards for medical devices. It...
- New products. // Drug Topics;Sep2010, Vol. 154 Issue 9, p53
The article offers news briefs related to over-the-counter (OTC) drugs. The U.S. Food and Drug Administration (FDA) has approved the analgesic Butrans Transdermal System Chill from Purdue Pharma LP. Kamada Ltd. has announced FDA approval of Glassia, a treatment of emphysema. GlaxoSmithKline has...
- FDA Actions. // Critical Care Alert;Jan2008 Pharmacology Watch, p2
The article reports on the approval of the over-the-counter sales of Zyrtec-D, which is a cetirizine five milligram (mg) plus pseudoephedrine hydrochloride 120 mg, by the U.S. Food and Drug Administration (FDA). It is recommended for adults and children aged 12 years and older. It is also...