Pozen submits response on migraine drug
CHAPEL HILL, N.C. In response to an approving letter from the FDA, drug developer Pozen Inc. submitted data for its new migraine drug, the company announced Monday.
Pozen and partner GlaxoSmithKline recently met with the FDA to discuss the companies’ future plan for fulfilling the agency’s appeal for the information. Pozen provided the FDA with data from three non-clinical studies for its proposed migraine medication called Trexima.
In addition to the study results submission, the company also provided the FDA with a required routine safety update and revised product labeling. The FDA may take up to six months to review this submission, although the company has requested a 60-day review.
The company also said it will launch a clinical evaluation of the Trexima’s potential of having genotoxicity, any toxic change to DNA’s structure or function.
Results of genotoxic testing will be available for submission to and review by the FDA, if required, during the first quarter of 2008.
“Although we believe that our submission addresses FDA’s concern regarding the genotoxic potential of Trexima, we feel it is prudent to conduct this clinical trial so that we can provide this information without delay, if required,” said Marshall Reese, executive vice president of product development.
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.