FDA pediatric committee to discuss side effects of Tamiflu
WASHINGTON The Food and Drug Administration’s Pediatric Advisory Committee will meet on Nov. 27 to review the neurological and behavioral side effects in children who have taken the influenza treatment Tamiflu, according to Bloomberg.
This comes two years after the drug was linked to the deaths of at least a dozen Japanese children. Roche Holding, which manufactures the drug, claims the flu and not the drug caused the reported side effects in the children.
Nonetheless, governments are stockpiling the medication in case of a flu breakout.
The committee also plans to reviews reports linked to other medications such as Serevent, Provigil, Emtriva, Gleevec, Azopt and Betaxon.
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.