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New draft standards from the U.S. Pharmacopeial Convention could bring dramatic changes to Rx labels as early as 2012. Changes to USP Chapter 17, Prescription Container Labeling, include larger font, placement of the most important information at the top, more understandable language, and more white space.

OTC Product News

In this section we showcase products and product news that ran up against space limitations or fell outside the parameters of recently featured categories in the print edition. Look for more OTC Product News in upcoming issues of the Drug Topics e-newsletter.

With several blockbusters going off patent, Secretary Kathleen Sebelius of the U.S. Department of Health and Human Services asked the office of the Assistant Secretary for Planning and Evaluation to ?examine barriers to and identify opportunities for increasing generic use.?

The United States Department of Health and Human Services division of Substance Abuse and Mental Health Services Administration has released a study examining trends of admissions to U.S. substance abuse treatment facilities of people aged 12 years and over, during the period from 1998 to 2008.

FDA has approved vilazodone HCl tablets (Viibryd, Clinical Data) for the treatment of adults with major depressive disorder.

FDA has sent MannKind Corp. a complete response letter regarding the company?s New Drug Application for Afrezza (insulin human [rDNA origin]) Inhalation Powder for the treatment of adult patients with types 1 and 2 diabetes for the control of hyperglycemia.

FDA has approved a label update to include a 200-mg formulation of etravirine (Intelence, Tibotec Therapeutics), a non-nucleoside reverse transcriptase inhibitor indicated for the treatment of HIV-1 in adults resistant to an NNRTI and other antiretroviral agents.

FDA approved spinosad (Natroba, ParaPRO LLC) Topical Suspension 0.9% for the treatment of head lice infestation in patients aged 4 years and older. Natroba is a topical drug product and should be applied only to the child's scalp or hair.

Severe liver injury, including 2 cases of acute liver failure leading to liver transplant in patients treated with the medication, has been associated with the use of dronedarone (Multaq), according to an FDA Drug Safety Communication announcement.

The first trial to provide evidence that drugs used to treat HIV can also help to prevent HIV infection among men who have sex with men (when combined with other prevention strategies) was reported late November online in the New England Journal of Medicine.

The Infectious Diseases Society of America is set to release its first guidelines for the treatment of the increasingly common and potentially deadly methicillin resistant Staphylococcus aureus infection.