FDA update on brand drugs for September 29, 2009

[chantell.reagan]

Folotyn (pralatrexate) injection by Allos Therapeutics
Accelerated approval: treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)

•Link to FDA letter
•Link to prescribing information

Stelara (ustekinumab) injection by Centocor Ortho Biotech
Approval: human interleukin-12 and -23 antagonist indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy

•Link to FDA news release 9/09
•Link to prescribing information
•Link to NICE technology appraisal 9/09

Labeling changes:

Januvia (sitagliptin) and Janumet (sitagliptin/metformin)
Labeling change: revising prescribing information to include information on reported cases of acute pancreatitis in patients using these products

•Link to FDA: Information for Healthcare Professionals - Acute pancreatitis and sitagliptin (marketed as Januvia and Janumet)

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