Wyeth Pharmaceuticals, a division of Wyeth, has announced that the Food and Drug Administration (FDA) has extended its review of the firm's Biologics Licence Application for Prevan 13 by 90 days.
The timeframe for the Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) review has now been altered and will run until December 30th, rather than September 30th 2009.
Pravnar 13 is being evaluated as an active immunisation of infants and young children for the prevention of invasive disease and otitis media caused by 13 Streptococcus pneumoniae (S pneumoniae) serotypes.
"This is a significant application that is under priority review and we are working closely with the FDA on the review, including conduct of the pre-approval inspections," commented Emilio Emini, executive vice-president of vaccine research and development at Wyeth.
Last week, the company announced the submission of an extension application to the European Medicines Agency for RELISTOR (methylnaltrexone bromide) pre-filled syringes.See all the latest jobs in Pharmaceutical