Wyeth Receives Approvable Letter From FDA For TYGACIL For The Treatment Of Patients With Community-Acquired Pneumonia (PharmaceuticalOnline)
Wyeth Pharmaceuticals, a division of Wyeth, announced recently that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for the first-in-class antibiotic TYGACIL (tigecycline) for the treatment of adult patients with community-acquired pneumonia (CAP).

FDA Proposes New Drug Labeling Requirements Detailing Risks To Pregnant Women, Fetuses (Medical News Today)
On Wednesday, FDA released a proposed rule to require that updated safety information detailing the risks of drugs for pregnant and breastfeeding women -- as well as for fetuses and breastfed infants -- be added to drug labels, the Wall Street Journal reports. FDA began requiring information on drugs' risks for pregnant women in 1979 and has not changed the policy since then.

Wyeth Receives FDA Fast Track Designation For Its 13-Valent Pneumococcal Conjugate Vaccine For Infants And Toddlers (PharmaceuticalOnline)
Wyeth Pharmaceuticals, a division of Wyeth, recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company's investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers. Wyeth is seeking a pediatric indication for active immunization against invasive pneumococcal disease (IPD) and otitis media caused by serotypes ...