Latest Fda Approved Drugs Information Systems

August 22, 2012 — An outbreak of West Nile virus infections that has claimed more than 3 dozen lives this year could shape up to be worst ever, the US Centers for Disease Control and Prevention (CDC) announced today. The number of reported cases jumped in just a week's time from 693, as of August 14, to 1118, as of August 21, according to the agency. During that same period, the number of reported deaths rose from 26 to 41. "We're in the midst of one of the largest outbreaks of West Nile virus ever seen," said Lyle Petersen, MD, MPH, director of the CDC's Division of Vector-Borne Infectious Diseases, in a press briefing today. The number of disease cases reported in 2012 through August 21 is the highest for this time frame since the mosquito-borne virus was first detected in the United States in 1999. West Nile virus infections typically peak in mid-August, but the CDC expects the case count to continue rising through the end of September because of delay...

FDA Drug Info Rounds is a series of training videos for practicing clinical and community pharmacists.  Drug Info Rounds is brought to you by pharmacists in the FDA's Center for Drug Evaluation and Research (CDER), Office of Communications (OCOMM), Division of Drug Information (DDI).  Pharmacists in DDI answer hundreds of questions everyday about drug products and FDA actions.  Our goal is to provide important and timely drug information to pharmacists so they can help patients make better medication decisions. Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the U.S. Patent and Trademark Office anywhere along the development lifeline of a drug and can encompass a wide range of claims. Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to a New Drug Application (NDA)...

The U.S. Food and Drug Administration today issued a new warning to consumers about the potential health risks of two products marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The products, Reumofan Plus and Reumofan Plus Premium, contain several potentially harmful active pharmaceutical ingredients that are not listed on the product labels.   The FDA has received dozens of additional adverse event reports, including death and stroke, associated with the use of Reumofan Plus since the agency issued its first warning about the product on June 1, 2012. Other reports include liver injury, severe bleeding, sudden worsening of glucose (sugar) control, weight gain, swelling, leg cramps and withdrawal syndrome, and adrenal suppression.   Consumers who are taking these products or who have recently stopped taking Reumofan Plus or Reumofan Plus Premium should immediately consult a health care profes...

August 21, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Doxycycline doxycycline hyclate Injectable; Injection Pfizer Approval Dulera formoterol fumarate; mometasone furoate Aerosol, Metered; Inhalation Merck Sharp Dohme Labeling Revision Mycophenolic Acid mycophenolic acid Tablet, Delayed Release; Oral Apotex Inc Approval Veramyst fluticasone furoate Spray, Metered; Nasal Glaxosmithkline Efficacy Supplement with Clinical Data to Support August 20, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Combivent albuterol sulfate; ipratropium bromide Aerosol, Metered; Inhalation Boehringer Ingelheim Labeling Revision Epi E Z Pen Jr epinephrine Injectable; Intramuscular Meridian Medcl Techn Labeling Revision Epipen epinephrine Injectable; Intramuscular Meridian Medcl Techn Labeling Revision Epipen E Z Pen epinephrine Injectable; Intramuscular Meridian Medcl Techn Labeling Revision Epipen Jr. epinephrine Injectable; In...

August 22, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Nedocromil Sodium nedocromil sodium Solution; Ophthalmic Akorn Inc Approval Ortho Evra ethinyl estradiol; norelgestromin Film, Extended Release; Transdermal Janssen Pharms Labeling Revision

On Monday, August 27, 2012, the U.S. Food and Drug Administration approved Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate), a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection. Stribild contains two previously approved HIV drugs plus two new drugs, elvitegravir and cobicistat. Elvitegravir is an HIV integrase strand transfer inhibitor, a drug that interferes with one of the enzymes that HIV needs to multiply. Cobicistat, a pharmacokinetic enhancer, inhibits an enzyme that metabolizes certain HIV drugs and is used to prolong the effect of elvitegravir. The combination of emtricitabine and tenofovir disoproxil fumarate, approved in 2004 and marketed as Truvada, blocks the action of another enzyme that HIV needs to replicate in a person’s body. Together, these drugs provide a complete treatment regimen for HIV infection.

Preamble Keeping pace with the stream of new data and evolving evidence on which guideline recommendations are based is an ongoing challenge to timely development of clinical practice guidelines. In an effort to respond promptly to new evidence, the American College of Cardiology Foundation (ACCF)/American Heart Association (AHA) Task Force on Practice Guidelines (Task Force) has created a "focused update" process to revise the existing guideline recommendations that are affected by the evolving data or opinion. New evidence is reviewed in an ongoing fashion to more efficiently respond to important science and treatment trends that could have a major impact on patient outcomes and quality of care. Evidence is reviewed at least twice a year, and updates are initiated on an as-needed basis and completed as quickly as possible while maintaining the rigorous methodology that the ACCF and AHA have developed during their partnership of more than 20 years. These focused updat...