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Covidien Spinning Off Drug Unit
Covidien plans to spin off its pharmaceuticals division into a separate company. The drug unit generates about $2 billion in annual sales which includes its products Exalgo, a 24-hour extended release opioid, and Pennsaid, a topical anti-inflammatory medication.
The action is expected to take up to 18 months to complete. This action will not affect the company's ability to make acquisitions. The pharmaceutical company will probably be based in Ireland, partly for tax purposes; the main operations of the drug business are currently in St. Louis, Missouri.
http://www.businessweek.com/news/2011-12-15/covidien-spinning-off-drugs-unit-to-focus-on-pain-management.html
[Editor's Note: First the companies merge and then they spin off�each time the upper management seems to make millions of dollars for making these wise and remarkable decisions!]
Hospitals Cut Doses as a Result of Drug Shortage
Hospitals have had to cut doses and ration supplies of nutrition drugs and disinfectant products. The situation is part of a broader drug shortage that has federal health officials rethinking how they monitor the nation's pharmaceutical supply. While shortages of chemotherapy and anesthesia drugs have received much attention, now they are looking at the shortage of nutrition drugs and disinfectant products
http://online.wsj.com/article/SB10001424052970204844504577098870278510832.html
Safe Preparation and Administration of Intravitreal Bevacizumab Injections
The off-label use of bevacizumab (Avastin) for neovascular age-related macular degeneration makes a more affordable treatment than ranibizumab (Lucentis) for preventing blindness. Since bevacizumab is supplied in 100-mg and 400-mg vials, it is often compounded into individual doses for intravitreal injections. During this process, contamination can occur during preparation or administration.
In Tennessee, three recent clusters of endophthalmitis secondary to alpha-hemolytic streptococcus, after intravitreal injections of bevacizumab in nine patients occurred. Four patients lost eyesight and one also had meningitis and encephalitis. Two completed investigations have implicated the same compounding pharmacy. What was observed was a situation of noncompliance with face-mask usage as outlined in the standards for sterile compounding developed by the U.S. Pharmacopeia, known as USP <797>. Tennessee has rules that pertain to the compounding and dispensing of sterile preparations but does not require adherence to USP <797>. The rules of the Tennessee Board of Pharmacy require the wearing of a mask only if no laminar-flow hood is used or if the pharmacist or technician has a respiratory condition that may result in contamination of sterile products. The pharmacist at the implicated pharmacy compounded bevacizumab under a laminar-flow cabinet with no vertical barrier; the pharmacist wore no mask and spoke during the procedure. It was hypothesized that this resulted in contamination.
http://www.nejm.org/doi/full/10.1056/NEJMc1105759
Generic Drug User Fees
After months of meetings and negotiations with the drug and chemical industries, the FDA has released a draft of the goals of the Generic Drug User Fee Act. The act would give the FDA $1.5 billion over five years through industry user fees. The law, also known as GDUFA, has been a goal of the generic drug industry to expedite the agency's review of generic drugs and whittling down its massive backlog of thousands of applications. The law would also enhance the FDA's ability to inspect foreign manufacturing sites.
http://www.drugstorenews.com/article/fda-releases-draft-gdufa-goals?utm_source=GoogleNews&utm_medium=Syndication&utm_campaign=ManualSitemap
FDA Approves Topical Oxybutynin 3% gel
A topical oxybutynin 3% gel has been approved by the FDA for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. The gel is applied once daily, in 84 mg doses, to the thigh, abdomen, upper arm, or shoulder through a metered-dose pump.
Since the drug is applied topically, it is not metabolized in the liver and has a lower adverse event profile than oral formulations.
http://www.medpagetoday.com/Urology/UrinaryIncontinence/30104
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