Regulatory Roundup: FDA Authorizes Emergency Use of Investigational Drug for Treatment of Certain H1N1 Flu Patients, More...

Published on: 

ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, FDA's DDMAC issues Warning Letter to King Pharmaceuticals; draft guidance released for SPL standards for content of labeling.

The US Food and Drug Administration authorized the emergency use of the investigational antiviral drug peramivir intravenous (IV) for 2009 H1N1 influenza in certain adult and pediatric patients who are admitted to a hospital. Certain conditions must be met in order to use IV peramivir in these populations and situations, according to an agency press release. FDA took this action in response to a request from the US Centers for Disease Control and Prevention.

FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) sent a Warning Letter to King Pharmaceuticals (Bristol, TN) over two video news releases for its painkiller Embeda (morphine sulfate and naltrexone hydrochloride). The letter calls the videos false or misleading because they “omit and minimize the risks associated with EMBEDA, fail to present the limitations to its approved indication, and present misleading claims” and violate sections (e)(5) and (e)(6)(i) of 21 CFR 202.1, Prescription-drug advertisements.


FDA released this week a draft guidance for industry-SPL Standard for Content of Labeling Technical Qs & As. The guidance provides information to applicants who submit content of labeling to FDA as part of a marketing application using the structured product labeling standard (SPL) in extensible markup language (XML). This is revision 1 of a guidance of the same name that was issued in December 2005. The guidance has been revised to reflect changes in the technology since 2005 and to harmonize the submission of SPL in the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research. The Q&A document provides answers to common questions about preparation and submission of SPL standards and content-labeling documentation. FDA said it anticipates that additional guidance will be provided as new questions arise about the use of SPL.