FDA NEWS

Solodyn (minocycline HCL) Extended Release Tablets 90 mg
Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine).

FDA Approves Entereg to Help Restore Bowel Function Following Surgery
The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses.

Enbrel (etanercept)
Prescribing information revised to include a BOXED WARNING regarding the risk of infection including tuberculosis.

Manufacturer Removes Remaining Stocks of Trasylol
Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician�s stock. The FDA will work with Bayer to ensure a smooth and complete process.

Labels: FDA