FDA gives Teva tentative approval to generic Maxalt, Evista
JERUSALEM, Israel The Food and Drug Administration has granted tentative approval to Teva for its generic version of Merck’s migraine drug Maxalt, in 5 mg and 10 mg, and Eli Lilly’s osteoporosis drug Evista, in 60 mg.
Maxalt’s generic, rizatriptan benzoate, will be launched when the brand’s patent expires in June 2012. Evista’s generic, raloxifene hydrochloride, will hopefully be launched once Teva settles patent litigation in the U.S. District Court for the Southern District of Indiana.
Evista had sales of about $691 million in the United States in 2007, and Maxalt had sales of about $193 million in the United States for 2007, according to IMS Health.
Also, Teva was informed that the FDA has concluded that its generic version of GlaxoSmithKline’s antidepressant Wellbutrin was safe and effective. Some patients had complained about experiencing depression after switching from the brand to the generic.
The FDA detected slight differences between Teva’s formulation and the original, but said they were small enough to be inconsequential.
Combination of Celebrex and Lipitor may prove effective in fighting prostate cancer
WASHINGTON A new combination between the drugs Celebrex, which lowers cholesterol, and Lipitor, an anti-inflammatory drug, can be used in controlling prostate cancer before it becomes deadly, according to published reports.
The study first cultured prostate tumors in mice, and then gave the mice either Lipitor or Celebrex, or a combination of the two. All proved to be successful in halting cancer growth. The study also found that putting a combination of Lipitor and Celebrex in lower doses was most effective. Scientists have yet to find why these two combinations have such a positive effect on fighting prostate cancer.
Prostate cancer is the second-leading cancer killer in men, and the presence of the two drugs may help stop the progression of the cancer before it gets worse, according to the study.
Even though this discovery has gone only through preliminary trials, many are excited by the positive implications it may have for prostate cancer. According to K. Scott Coffield, a professor of surgery at Texas A&M Health Science Center College of Medicine and a urologist-oncologist at Scott & White, “They need to come up with the molecular mechanics and then take it back to clinical trials. It’s early but it’s interesting and that’s wonderful.”
The research will be presented at the American Association for Cancer Research’s annual meeting in San Diego.
Snabes tapped as BioSante Pharmaceuticals vice president of clinical development
LINCOLNSHIRE, Ill. BioSante Pharmaceuticals announced Michael Snabes as the company’s new vice president of clinical development, according to published reports.
Snabes will be responsible for the development of LibiGel, which is a testosterone gel for the treatment of female sexual dysfunction. Snabes has a history with BioSante as he served as medical consultant of BioSante since November 2005, where he focused on clinical and regulatory matters, according to published reports.
He is a board certified reproductive endocrinologist, and has a Ph.D. in physiology and reproductive endocrinology. According to published reports, he also played major role in the submission of BioSante’s New Drug Application Elestrin, which now has been approved fully by the Food and Drug Administration.
“We are very pleased that Michael has agreed to accept this position with BioSante,” said Stephen Simes, president and chief executive officer of BioSante. “Michael has been an important part of our clinical team for more than two years and his full-time involvement will help us to implement fully and accelerate our development of LibiGel in the treatment of FSD, specifically hypoactive sexual desire disorder in menopausal women.”