FDA update on brand drugs for February 25, 2010

[chantell.reagan]

Cayston (aztreonam for inhalation solution) by Gilead
Approval: to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa)
•Of note: Cayston's safety and efficacy have not been established in pediatric patients below the age of 7, patients with forced expiratory volume in one second (FEV1) of less than 25 percent or greater than 75 percent predicted, or patients colonized with Burkholderia cepacia

•Link to Gilead press release 2/10
•Link to prescribing information

Menveo (Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) by Novartis
Approval: active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in people 11 to 55 years of age

•Link to Novartis press release 2/10
•Link to FDA letter
•Link to prescribing information

Prevnar-13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) by Wyeth
Approval: for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, for use in children 6 weeks through 5 years of age AND for the prevention of otitis media caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F

•Link to FDA letter
•Link to prescribing information

New dosage form:

Mirapex ER (pramipexole dihydrochloride) extended-release tablets by Boehringer Ingelheim
Approval: once-daily treatment option for the signs and symptoms of early idiopathic parkinson's disease (PD)

•Link to News article 2/10

Expanded indications/labeling changes:

Rituxan (rituximab) by Genentech
Expanded indication: in combination with fludarabine and cyclophosphamide (FC) for people with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL)

•Link to Genentech press release 2/10
•Link to prescribing information

Sources:

U.S. Food and Drug Administration. Drugs@FDA. Available at: Drugs@FDA
U.S. Food and Drug Administration. Center for Biologics Evaluation and Research. Available at: CBER