All News

FDA has issued a complete response letter to Eisai for its rabeprazole sodium extended-release capsules, 50 mg, an investigational proton pump inhibitor (PPI) under review for the healing and long-term maintenance of healing and symptom resolution of erosive GERD, and for the treatment of daytime and nighttime heartburn and other symptoms of non-erosive GERD.

FDA has issued a complete response letter for Orexigen?s and Takeda?s Contrave (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.

NCPA is holding the first of 3 pharmacy ownership workshops for 2011 in Atlanta, February 4 to February 6.

NACDS Mobile is the association?s new mobile website that serves as a ?guide on the go? specifically designed for ease of use on any smart phone with a web browser.

A group of regulatory, industry, and consumer groups has created a new voluntary guideline to ensure that nutritional supplement companies have the necessary data to support expiration dating on product labels.

Half of Americans polled don't think vaccines cause autism. However, 18% are convinced that vaccines, like the MMR vaccine, can cause the disorder, and another 30% aren't sure, according to a new Harris Interactive/HealthDay poll.

The Centers for Disease Control included a botanical treatment for genital warts in its recently revised 2010 CDC Sexually Transmitted Diseases Treatment Guidelines.

The Michigan Pharmacy Association criticized a new report suggesting that the state could save $146 million by moving fee-for-service Medicaid recipients to managed care programs.

Despite the electronic-tracking systems for pseudoephedrine that have been implemented in several states, methamphetamine-related activity is on the rise.

Small-molecule drugs in the United States will experience the greatest degree of brand erosion as patents of many of the most popular drugs expire during the next several years, leaving them exposed to generic competition, according to a report published by Datamonitor.

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.

One pharmacist fantasizes about a world that draws the distinction between fast food and pharmacy.

Researchers recently found that extreme obesity can increase patients? risk of death from the H1N1 influenza virus.

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.

The National Association of Chain Drug Stores Foundation announced the 2010 recipients of the NACDS Foundation Pharmacy Student Scholarship Awards.

Pfizer Inc. recently launched a syringe that aims to help hemophilia patients lead active lives and take care of their condition faster and easier.

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.?

A new study conducted by CVS Caremark and published in Health Affairs, found that among patients who had increased drug costs but were adherent with their medications, a ?substantial medical savings as a result of reductions in hospitalization and emergency department use? was realized.

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.

Executives with the American Society of Health-System Pharmacists and other groups are urging Congress to pass federal legislation to ease drug shortages in the United States.

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

FDA has approved the premix formulation of vancomycin injection, USP (750 mg/150 mL) (Baxter). Vancomycin is an antibiotic used to treat severe infections caused by susceptible strains of methicillin-resistant Staphylococcus aureus and/or treat patients who are penicillin-resistant.

Bayer instructed patients to immediately discontinue use of the Triad alcohol prep pads included in Betaseron (interferon beta 1-b) packaging and to dispose of those pads in the trash.

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.

Concern that its drug vorapaxar, in trial for its potential to prevent clots, actually increased the risk of bleeding in stroke victims has prompted Merck & Co. to halt a late-stage study of the drug, the Associated Press reported.

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.

The impact of generic drugs ? which now account for more than 70% of all prescriptions dispensed in the United States ? will continue to increase as some of the world?s most-prescribed products lose their patent protection in 2011 and begin facing generic competition.

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.