FDA update on brand drugs for February 4, 2010

[chantell.reagan]

Oleptro (trazodone hydrochloride) extended-release tablets by Labopharm
Approval: treatment of major depressive disorder (MDD) in adults

•Link to Labopharm press release 2/10

Xiaflex (collagenase clostridium histolyticum) injection by Auxilium
Approval: treatment of adult Dupuytren's contracture patients with a palpable cord; launch planned for late March

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

Expanded indications/labeling changes:

Tykerb (lapatinib) and Femara (letrozole) by GSK and Novartis
Expanded indication: to treat hormone-positive and HER2-positive advanced breast cancer in postmenopausal women

•Link to GSK press release 1/10
•Link to Tykerb prescribing information

Zyprexa (olanzapine) by Lilly
Labeling change: When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia

•Link to FDA Medwatch Zyprexa (olanzapine): Use in Adolescents

Safety issues:

Videx/Videx EC (didanosine) by BMS
Safety issue: may cause non-cirrhotic hypertension in patients, which was discovered through 42 post-market, adverse event reports

•Link to news article 1/10

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