|
Cyanocobalamin Injection Recalled
American Regent announced on April 2 the recall of three lots of Cyanocobalamin Injection, USP. The reason for the recall is that cracks may form at the bottom of the vials, potentially introducing glass particles or rendering the medication nonsterile. The cracks were discovered on vials from Lot 1683, but Lots 1662 and 1679 are also being recalled as a precautionary measure.
The Lots consist of 1-mL vials containing 1000 micrograms/mL of cyanocobalamin and have an expiration date of November 2013; it is manufactured for American Regent by Luitpold Pharmaceuticals. These Lots should NOT be used, they should be quarantined and arrangements made to return the vials for credit.
Contact American Regent's Customer Service Department at 800-645-1706 Monday-Friday from 8:30 am to 7:00 pm.
Doxil Supply May be Increased by J&J by September
Johnson & Johnson is exploring ways to resume production of Doxil by September of 2012 after a production shutdown at a supplier last year contributed to a shortage. Boehringer Ingelheim's Ben Venue Laboratories factory in Ohio stopped production in November after regulators questioned product quality. The company has been distributing the limited remaining supply to patients under the Doxil C.A.R.E.S.
The FDA has given Caraco Pharmaceutical Laboratories Ltd. permission to import an unapproved drug from India with the same active ingredient as Doxil to ease pent-up demand for the medication. The FDA does allow temporary importation of unapproved drugs in rare cases when there is a shortage of medications critical to patients. Caraco, a Detroit-based generic-drug manufacturer, will temporarily import the drug Lipodox from its Mumbai-based parent, Sun Pharmaceutical Industries Ltd.
http://www.bloomberg.com/news/2012-04-09/j-j-working-to-boost-supply-of-cancer-drug-doxil-by-september.html
Preventing Another Tricor Situation
The Archives of Internal Medicine has just published a study about the Abbott Laboratories fenofibrate saga. After studying years of prescription data, researchers concluded that branded versions of Tricor dominated the market long after key patents expired and even after generics were approved. This domination cost the U.S. healthcare system a lot of money. Basically, it is well known that Abbott tweaked fenofibrate formulations repeatedly to continue its hold on that market.
The published study suggest changes to policy that may prevent the Tricor strategy from being used by other pharmaceutical companies and reserve market exclusivity for products that offer true innovations and improvements to patient outcomes. As an example, the FDA could require that pharmaceutical companies settle pending lawsuits concerning the original drug before seeking NDA approval for the next-generation drug. Also, the FDA could require that companies market their reformulations under different brand names in an effort to make the changes more transparent. A possibility also includes policy changes, such as permitting generic substitution of bioequivalent formulations of the same drug at different doses or tweaking the FDA approval process for branded reformulations.
Source: Arch Intern Med. Published online April 9, 2012.
Risperdal Marketing Violated Law and May Cost J&J $1.2 Billion
A jury ruled that Johnson & Johnson officials misled Arkansas physicians and patients about the risks of Risperdal, and that the company's marketing campaign violated consumer-protection laws. The jurors in Little Rock, Arkansas deliberated about three hours before finding J&J and its Janssen unit engaged in "false or deceptive acts" by sending to more than 6,000 doctors across the state a 2003 letter touting Risperdal as safer than competing drugs. The state is seeking more than $1.25 billion in penalties over the Risperdal marketing campaign, and a judge will decide later whether to fine J&J.
This is the third jury verdict against J&J in cases where states alleged the company hid Risperdal's risks and tricked Medicaid regulators into paying more than they should have for the medicine. Louisiana and South Carolina juries also found the company's Risperdal marketing violated consumer-protection laws.
http://www.bloomberg.com/news/2012-04-10/j-j-s-risperdal-marketing-violated-law-arkansas-jury-rules-1-.html
| 
