Posted on 04/01/2010 in Pharmaceutical Company Product News Pfizer has revealed that, following its submission of a biologics licence application (BLA) for Prevnar 13 (Pneumococcal 13-valent conjugate vaccine [diphtheria CRM protein]), the Food and Drug Administration (FDA) has not yet completed its review of the treatment.
Due to this, the drug, which is a candidate 13-valent pneumococcal conjugate vaccine, will continue to be reviewed beyond the original prescription drug user fee action date of December 30th 2009.
Emilio Emini, chief scientific officer of vaccine research at Pfizer, said that the firm remains confident that the FDA will approve the treatment.
He added: "We will continue to work closely with the FDA to help expedite the completion of its review of our BLA."
Pfizer is seeking approval for Prevnar 13 to be used for the immunisation of infants and toddlers for the prevention of invasive diseases caused by the 13 Streptococcus pneumoniae (S. pneumoniae) serotypes.
Last month, Pfizer highlighted the results of a study which found that its Toviaz therapy was discovered to be more effective than existing alternatives when treating patients with urge urinary incontinence episodes.Other news stories from 04/01/2010
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