FDA approves Wyeth’s Tygacil as pneumonia treatment
COLLEGEVILLE, Pa. The Food and Drug Administration has approved a new use for a drug used to treat bacterial infections.
The agency approved Wyeth Pharmaceuticals’ Tygacil (tigecycline) for the treatment of community-acquired bacterial pneumonia. The previous approval was for the treatment of complicated skin and skin structure infections and complicated intra-abdominal infections.
The approval was based on results of two clinical trials conducted at 116 sites in 28 countries that compared the efficacy and safety of Tygacil with that of Johnson & Johnson’s Levaquin (levofloxacin) in people hospitalized with CABP.
“The approval of this new indication is timely,” Wyeth Pharmaceuticals SVP global medical affairs Joseph Camardo stated. “Antibiotic resistance continues to grow, and new antimicrobials are needed.”
FDA approves third Depakote generic
ROCKVILLE, Md. The Food and Drug Administration has approved a generic version of a drug used to treat epilepsy.
The agency approved Mylan’s divalproex sodium delayed-release tablets in the 125 mg, 250 mg and 500 mg strengths. The tablets are a generic version of Abbott Labs’ Depakote, used to treat seizures and convulsions.
Mylan’s generic of Depakote is the third approved this month.
Depakote had sales of $803 million during the 12 months ending in March 2008, according to IMS Health data.
FDA approves phase 3 study for autism treatment
RYE, N.Y. The Food and Drug Administration has allowed a phase 3 study of a drug for autism to commence.
Curemark announced Wednesday that it expected to begin the trials of the drug CM-AT at multiple sites across the United States during second quarter 2009.
“With one-in-150 children diagnosed with autism, we have children who are suffering, Curemark CEO Joan Fallon said in a statement. “We are very excited about the opportunity to enter a phase 3 trial for this ever-growing population of children.”