FDA update on brand drugs for January 28, 2010

[chantell.reagan]

Ampyra (dalfampridine) extended-release tablets by Acorda
Approval: potassium channel blocker indicated to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed

•Link to Acorda press release 1/10
•Link to prescribing information

Morphine solution 100mg/5ml by Roxane (drug already marketed, but without an approved NDA)
Approval: relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate

•Link to FDA news release 1/10
•Note: This is the only FDA approved morphine sulfate oral solution available at this concentration.

Victoza (liraglutide [rDNA origin]) injection), solution for subcutaneous use by Novo Nordisk
Approval: as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

•Link to FDA letter
•Link to prescribing information

Safety issues/labeling changes

Meridia (sibutramine) by Abbott
Labeling change: FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label stating that sibutramine is not to be used in patients with a history of cardiovascular disease, including:

* History of coronary artery disease (e.g., heart attack, angina)
* History of stroke or transient ischemic attack (TIA)
* History of heart arrhythmias
* History of congestive heart failure
* History of peripheral arterial disease
* Uncontrolled hypertension (e.g., > 145/90 mmHg)

•Link to FDA: Follow-Up to an Early Communication about an Ongoing Safety Review

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