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Warfarin Recall
A warfarin sodium recall has been announced by Bristol-Myers Squibb because of the possibility the tablets might contain doses that are too high. The recall applies to Coumadin Crystalline 5 mg tablets -- lot number 9H49374A -- in 1,000 count bottles, with a Sept. 30, 2012 expiration date. BMS said testing of a returned bottle identified a single tablet that had higher-than-expected potency.
There was a similar issue earlier this year when Upsher-Smith Laboratories recalled some of its generic warfarin product (Jantoven) because of the possibility of tablets with the wrong doses.
http://www.medpagetoday.com/ProductAlert/Prescriptions/26241
Abbott Laboratories gets FDA approval for Androgel 1.62% Formula
Abbott Laboratories has received approval for a new, more potent formulation of its testosterone gel. The approval is for treating men with hypogonadism or low testosterone, a condition associated with fatigue, depression and various sexual dysfunctions.
This new formula, Androgel 1.62 percent, delivers 40.5 milligrams of gel in two pumps of the canister. The older, Androgel 1% formulation included 50 milligrams in four pumps. The company says the two formulations are not interchangeable and both require a prescription.
The FDA approval is based on a study showing 78 percent of men using the gel had normal testosterone levels after one year of use. More and more, drug companies are targeting low testosterone as a new market opportunity. It is estimated that about 14 million American men are believed to have irregularly low testosterone levels, though only 1.3 million are being treated. The estimated U.S. market for testosterone therapies is $1.1 billion.
http://finance.yahoo.com/news/Abbott-gets-FDA-clearance-for-apf-1957904740.html?x=0
1,000 More Lawsuits Over Avandia to be Settled
$700 million to resolve about 12,000 suits has been agreed upon by Glaxo, alleging the drugmaker failed to warn consumers that Avandia could cause heart attacks and strokes. There are a total of about 5,300 state-court cases pending around the country. The company said last September it would stop promoting Avandia worldwide after regulators said the treatment would be withdrawn from the market in Europe and sales would be limited in the U.S. because of studies linking the drug to increased risks of heart attacks. Avandia sales fell 43 percent due to the restrictions, the company said. Avandia was once the world's best-selling diabetes medication and generated $3 billion in annual sales. A court in Los Angeles has already seen 2,400 former Avandia users settling their claims.
http://www.bloomberg.com/news/2011-05-04/glaxo-is-poised-to-settle-about-1-000-suits-over-avandia-drug-lawyer-says.html
Acetaminophen to be Reformulated
In order to try to curb overdoses of acetaminophen, Johnson & Johnson and other drug makers will switch to a single concentration in their over-the-counter remedies for infants and children. These medications now come in different concentrations depending on whether they are for infants or older children and this has made it confusing for parents to figure out how much to give, causing overdoses and, in rare cases, deaths.There were 14 hospitalizations in 2009 caused by pediatric versions of medicines containing acetaminophen, but no deaths.
http://online.wsj.com/article/SB10001424052748704322804576303440194765686.html
New Hair Growth Option
Latisse, the prescription eyelash-enhancing solution, is now being used on the scalp.
Three or four drops daily and the Allergan drug that has already won a following among women for helping them grow long, fluttery eyelashes, is now being used by men to treat baldness.
Although Latisse does not appear to be a silver bullet for hair loss, it does appear to work in much the same way as Rogaine or Propecia. That is, all three can strengthen and darken hair that grows from a dying follicle, but none can bring a dead one back to life. This results in an enhanced, refortified hairline rather than a brand new head of hair.
http://www.nytimes.com/2011/05/05/fashion/05SKIN.html?_r=1&partner=rss&emc=rss
FTC Reports Finding a 60 Percent Increase in Pharmaceutical Industry Deals That Delay Consumers' Access to Lower-Cost Generic Drugs
In 2010, pharmaceutical companies struck a record number of deals in which the manufacturers of branded products paid potential generic rivals and generic companies agreed to delay the introduction of their products, thus eliminating competition.
The FTC report found that the number of deals increased more than 60 percent, from 19 in FY 2009 to 31 in FY 2010. In general, the agreements reached in 2010 involved 22 different brand-name pharmaceutical products with combined annual U.S. sales of about $9.3 billion. These collusion-type deals to keep generics off the market are already costing consumers and taxpayers $3.5 billion a year in higher drug prices; a win-win proposition for the pharmaceutical industry, but a lose-lose for everyone else.
An FTC staff study has found that such settlements that include a payment delay generic entry by 17 months longer on average than those that do not include a payment.
http://pharmalive.com/news/index.cfm?articleID=778964&categoryid=9&newsletter=1
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