GlaxoSmithKline reiterated a plan to submit its key new lung drug, Relovair, for regulatory approval in mid-2012 despite releasing another batch of mixed clinical trial results on Friday, March 23, 2012. The new once-a-day inhaled medicine showed superiority to GSK’s existing twice-daily drug Advair in one trial for chronic lung disease, but not another. That …
A new study says girls younger than age 17 can safely use emergency contraception without a prescription, and that there’s no reason they should be kept from buying the drug over the counter. The study, published in this month’s Obstetrics & Gynecology, helped the Food and Drug Administration decide that the pill — also known …
We recently wrote about 2 new FDA ideas in order to get medications into patient’s hands faster, with one idea they are exploring to increase the number of available over the counter medications. In lieu of the discussion on expanding the list of drugs that can be bought without a prescription, it seems as if …
A generic drug used to save lives of our soldiers oversees is getting little attention in U.S. hospitals, where it might save even more lives. The drug, Tranexamic acid, is made by Pfizer in injectable form and by many generic companies in other forms. It has gotten heavy use in Iraq and Afghanistan for stanching bleeding. …
The Wingspan Brain Stent marketed by Stryker Corp. may be doing more harm than good, according to a report authored by U.S. Food & Drug Administration (FDA) staff. The Wingspan system has been on the market since 2005 and is used to open blocked arteries in the brain when clot-dissolving drugs do not work. It …
The timing of DePuy Orthopaedics’ 2009 decision to phase-out its now-recalled ASR hip implant devices is now being questioned. According to a report published in The New York Times, based in information obtained under the Freedom of information Act, the decision on the hip implant phase out was made just weeks after the company received …
U.S. health regulators have approved the first low-cost versions of Roche’s blockbuster osteoporosis drug Boniva, which is used to prevent bone fractures. Boniva, known generically as Ibandronate, is taken once a month to treat or prevent osteoporosis. The Food and Drug Administration said it approved generic versions of the drug from three companies: Apotex Inc., …
Another disturbing adverse reaction has now been linked to taking antidepressants during pregnancy. Based on a new study, common selective serotonin reuptake inhibitors (SSRIs), such as Paxil, Zoloft, Lexapro, Prozac and Celexa, have been linked to high blood pressure during pregnancy, called pregnancy induced hypertension. Pregnancy induced hypertension is sometimes linked with pre-eclampsia, a serious …
How is a medical device on the market for 2 years without the FDA being aware of it? According to a report from Bloomberg News, Johnson & Johnson’s Gynecare Prolift transvaginal mesh device product was brought to market in 2005, but the U.S. Food & Drug Administration (FDA) was not even aware that the device was …
Across the country, dozens of lawsuits against generic pharmaceutical companies are being dismissed because of a Supreme Court decision last year. This decision stated that generic companies did not have control, based on a 1984 law, what their labels said, and therefore could not be sued for failing to alert patients about the risks of …