FDA grants Wyeth fast track for infant pneumonia vaccine
COLLEGEVILLE, Pa. The Food and Drug Administration has granted fast track designation to Wyeth Pharmaceuticals’ 13-valent pneumococcal conjugate vaccine for infants and toddlers, Wyeth announced Thursday.
The vaccine includes six new serotypes of invasive pneumococcal disease in addition to the seven that its Prevnar Pneumococcal 7-valent Conjugate Vaccine already treats.
Pneumococcal disease is the number-one cause of vaccine-preventable death in children younger than 5, according to the World Health Organization. Caused by the bacteria Streptococcus pneumoniae, it is a family of illnesses comprising pneumonia, meningitis and upper respiratory tract infections.
Introduced in 2000, Prevnar achieved sales of $2.44 billion in 2007, according to Wyeth’s annual report.
Juvaris tests flu vaccine addition
NEW YORK Burlingame, Calif.-based Juvaris BioTherapeutics is testing an adjuvant for flu vaccines.
JVRS-100, as the drug is known, is designed to augment vaccines by stimulating the immune system. Testing will involve 128 patients who will receive the drug ad an flu vaccine.
The trial will test the safety and tolerability of the drug.
Teva announces generic Wellbutrin XL and Zyrtec syrup
NORTH WALES, Pa. Teva Pharmaceuticals has announced the availability of two new generic drugs, Cetirizine hydrochloride syrup, the generic of Pfizer’s allergy medication Zyrtec syrup and Budeprion XL 150 mg, the generic of GlaxoSmithKline’s seasonal affective disorder medication Wellbutrin XL 150 mg.
Cetirizine Hydrochloride Syrup is available in a 5 mg/5 mL strength, in bottle sizes of 120 mL and 473 mL. Also, with the addition of this new strength, Teva now offers Budeprion XL tablets in 150 mg and 300 mg strengths, in bottle sizes of 30 and 500.
Zyrtec syrup has sales of $177 million in 2007 and Wellbutrin XL had sales of $992 million in 2007, according to drugs.com.