FDA Approves Lilly's Testosterone Treatment Using New Delivery Site
Eli Lilly has announced the FDA has approved Axiron as a replacement therapy for men with low testosterone. Axiron is the first testosterone topical solution approved for use through an armpit applicator. Other testosterone products include tablets, injections, and gels.
http://www.businessweek.com/ap/financialnews/D9JMHOG80.htm
SmithKline Beecham Wrote Book Under 2 Physicians' Names
In a 1999 book teaching family physicians how to treat psychiatric disorders, two physicians provided acknowledgment in the preface for an "unrestricted educational grant" from a major pharmaceutical company.
However, SKB actually had much more involvement than that simply stated in the book, Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care. GlaxoSmithKline (GSK) provided a grant that paid for a writing company to develop the outline and text for the two named authors.
http://www.nytimes.com/2010/11/30/business/30drug.html?_r=1&scp=1&sq=%2b%22National+Institutes+of+Health%22&st=nyt
Two More Companies Changing U.S. Ownership and/or Location Genzyme Transfers All Fill and Finish for U.S. from Massachusetts Plant to Ireland
Genzyme announced that it has moved the last stage of production out of its Allston, Massachusetts, plant for drugs sold in the U.S. An FDA consent decree required the company to make a number of changes. All fill and finish activities for Cerezyme, Myozyme, Fabrazyme, and Thyrogen for the U.S. market have been transferred to Genzyme's Waterford, Ireland plant at an external contract manufacturer.
http://pharmalive.com/news/index.cfm?articleID=746415&categoryid=9&newsletter=1
GSK Sells to Dr. Reddy's It's U.S. Bristol, TN Penicillin Facility and Products
GSK and Dr. Reddy's Laboratories announced that the companies have signed an agreement relating to GSK's U.S. oral penicillin facility and product portfolio. Under the agreement, GSK will transfer ownership of its penicillin manufacturing site in Bristol, Tennessee and rights for the Augmentin� and Amoxil� brands in the U.S. to Dr. Reddy's. GSK will retain the existing rights for these brands outside the U.S.
http://pharmalive.com/news/index.cfm?articleID=746252&categoryid=9&newsletter=1
Cancer Drugs Affected By Ongoing Shortages
Chemotherapy drugs are among those highest in demand of those drugs considered short in supply. ASHP maintains a list of all medications and vaccines in short supply that now numbers more than 140. The FDA also maintains its own list that is shorter because it tracks only drugs deemed medically necessary. More information is available at:
http://blogs.wsj.com/health/2010/11/23/cancer-drugs-affected-by-ongoing-shortages/
Popular Painkillers Taken Off the Market
Although still in wide use more than a half-century after its introduction, Darvon and Darvocet and their generic counterparts are in the process of being removed from the U.S. marketplace. The FDA's decision, based on data showing a risk of serious heart rhythm abnormalities, caps years of controversy about the drugs side effects, known generically as propoxyphene-which was first approved by regulators in 1957.
Propoxyphene has been estimated by the FDA to have been used by 10 million people in 2009, with most of them receiving the drug in combination with acetaminophen, a compound known by the Darvocet trade name. Data about heart toxicity cited by the FDA in Friday's announcement was available from an animal study that was conducted 30 years ago.
This withdrawal will hurt a small number of patients who can't tolerate other painkillers, but for most patients there are many alternatives, such as oxycodone, morphine, and Nucynta.
http://www.latimes.com/news/nationworld/nation/wire/sc-dc-1120-fda-darvon-20101119,0,3731927.story
1,400 Sales Positions to Be Cut From U.S. Unit
Swiss drug maker Novartis AG announced it will eliminate 1,400 U.S. sales jobs by January 1. The company will cut the jobs from the sales force of its general medicines business, as sales at that business will decline after the patent on Diovan expires. The marketing exclusivity on Diovan expired, and the patents protecting Diovan and related products start to expire in March 2012.
Novartis has 6,449 employees in its U.S. general medicines business, and this situation will eliminate about 22 per cent of the staff of that business. The company said it has 18,519 employees in the U.S. and about 100,000 worldwide. Novartis' U.S. operations are based in East Hanover, New Jersey.
http://pharmalive.com/news/index.cfm?articleID=747461&categoryid=9&newsletter=1
|