FDA update on brand drugs for March 4, 2010

[chantell.reagan]

Exalgo (hydromorphone extended-release tablets) by CombinatoRx
Approval: for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time

•Link to FDA letter
•Link to prescribing information

Vpriv (velaglucerase alfa for injection) by Shire
Approval: for long-term enzyme replacement therapy (ERT) for pediatric and adult patients with type 1 Gaucher disease

•Link to FDA letter
•Link to prescribing information

New dosage form:

Norditropin FlexPro [somatropin (rDNA origin) injection] prefilled pen by Novo Nordisk

•Link to Novo Nordisk press release 3/10
•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