FDA to extend review of Tysarbi
The Food and Drug Administration has told Elan and Biogen Idec that they will extend its regulatory review of Tysarbi as a treatment for Crohn’s diseases by up to three months.
Both companies were informed by the FDA that they need additional time to review information regarding Tysarbi’s risk management plan for Crohn’s disease. The three-month period should end on Jan. 13, 2008.
Approximately one million people worldwide have Crohn’s disease, a chronic and progressive inflammatory disease of the gastrointestinal tract, which commonly affects both men and women.
Wyeth hit with $134.5 million in Nevada lawsuit
RENO, Nev. Wyeth has been ordered by a Washoe county court to pay more than $43 million each to three northern Nevada women who claimed that the company’s hormone replacement drugs, Prempro and Premarin caused their breast cancer, according to the Reno Gazette-Journal.
The jury said the drugs were defective and found the company negligent for producing, manufacturing and selling them. The jurors awarded $7.5 million to each woman in past damages and $36 million-$40 million in future damages.
The jurors still have to decide whether the company is liable for punitive damages. Wyeth is also fighting about 5,300 similar lawsuits involving 7,800 women in state and federal courts across the country.
Teva sues Apotex over Coreg infringement
TRENTON, N.J. Teva has sued Apotex to prevent it from selling a generic version of the heart medication Coreg, according to Bloomberg.
The two companies, as well as other generic drug makers, received approval from the Food and Drug Administration to sell a generic version on Sept. 5. Teva says it owns four patents that cover various forms and processes to make the generic, carvedilol. The company also said that Apotex might have to buy the compound made using the patented process in order to sell the generic.
The lawsuit was filed yesterday in a federal court in New Jersey. Coreg had sales of $853.8 million in the first six months of 2007.