FDA rejects Labopharm’s Tramadol after response to second approvable letter
WASHINGTON Labopharm’s appeal of a second approvable letter from the Food and Drug Administration for a once daily formulation of its pain drug Tramadol has been rejected by the agency.
The director of the Center for Drug Evaluation and Research’s Office of New Drugs, John Jenkins, “has suggested additional statistical analysis of existing data as a means to potentially satisfy the agency’s requirements,” according to Labopharm.
The method Jenkins is proposing is different from the method the FDA requested following its first approvable letter in May 2007, the company said. Jenkins also recommended the company meet with the agency prior to any resubmission.
Labopharm is trying to introduce the once-daily formulation of tramadol, which is its lead product, in various international markets, including Canada, France, Germany, Spain, Italy and the UK.
Despite solid fourth quarter, Wyeth cautious about 2008
MADISON, N.J. Wyeth released its 2007 fourth-quarter report and it showed that while the company profited in the fourth quarter, the company expects 2008 to be an off year, according to published reports.
Wyeth said net income for the three months that ended Dec. 31 rose to $1.02 billion from $855.4 million. Wyeth’s fourth-quarter sales rose 10 percent to $5.76 billion from $5.22 billion a year earlier. Sales of Effexor rose 3 percent to $968 million.
Wyeth, though, now is facing trouble for 2008, and it comes in the form of generic competition. Generic manufacturers recently began selling copycat versions of Wyeth’s drug Protonix, for heartburn, which is expected to erode sales of Wyeth’s product.
Wyeth said it planned on seeking lost profits and other damages from the generics companies in a patent-infringement trial expected later this year. Protonix had $1.9 billion in sales in 2007. Wyeth also faces potential new generic competition for two other major drugs, the antidepressant Effexor and antibiotic Zosyn.
Sales of Effexor rose 3 percent to $968 million, but those sales might take a hit if Sun Pharmaceuticals launches a tablet version of the extended release version of Effexor in the summer.
Protonix sales rose 10 percent to $461 million. But Wyeth has lost U.S. market exclusivity for the drug after generic drugmakers Teva Pharmaceuticals and Caraco Pharmaceutical Labs—owned by Sun—launched copycat versions, despite the existence of a patent set to expire in 2010. Wyeth this week began selling its own generic Protonix in partnership with Prasco Laboratories.
Wyeth said it now expects 2008 earnings of $3.35 to $3.49 per share, excluding certain items, representing a decrease of 1 to 5 percent from 2007 levels. Analysts had expected 2008 earnings of $3.54 per share. The company also expects to cut its 50,000-employee workforce by 4-to-6 percent during the middle of this year,
Teva launches generic Protonix
NORTH WALES, Pa. Teva has launched its newest drug, a generic version of the Wyeth acid reflux drug Protonix. The drug is named Pantoprazole Sodium Delayed-Release.
The drug will be available in both strengths of the brand, 20 and 40 mgs in bottles of 90.
“Our customers count on Teva for a continuous supply of new generic products,” stated John Denman, vice president of. Sales and Marketing. “With the launch of pantoprazole sodium delayed-release tablets we add another quality product to our broad line of affordable generic pharmaceuticals.
This launch comes just a day after Wyeth released their own generic version of the drug, in hopes of keeping some of the market share they would have lost due to generic competition. Near the end of this year, Teva and Sun Pharma had received approval to launch a generic version of Protonix.
The drug had sales of $2.5 billion in 2007, according to Wyeth.