Labopharm Inc., of Laval, Québec, Canada, has announced that it has received approval for Ryzolt (tramadol HCl extended-release tablets) in a once-daily formulation.

The FDA has reaffirmed its position that elevated LDL is a risk factor for heart attack, stroke, and sudden death, among other cardiovascular diseases, and that reducing LDL levels lowers the risk of these diseases.

The FDA has accepted an investigational new drug (IND) application from Medarex, Inc., for MDX-1203, the company's first antibody-drug conjugate (ADC). The ADC is made of a potent cytotoxic prodrug chemically linked with an anti-CD70 antibody.

The Glucocard 01-mini Blood Glucose Monitoring System from Arkray USA, Inc., of Minneapolis, the only such system that features interchangeable faceplates so users can personalize the look of their monitor, has received marketing clearance.

Gelnique (oxybutynin chloride) Gel 10%, the first and only topical gel for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, has received FDA approval.

Labopharm Inc., of Laval, Quebec, Canada, announced that it has received approval for Ryzolt (tramadol HCl extended-release tablets) in a once-daily formulation.

AMAG Pharmaceuticals, Inc., of Lexington, Mass., has received a Complete Response letter from the FDA regarding ferumoxytol for the treatment of iron deficiency anemia (IDA) in CKD patients.

Abbott Laboratories, in Abbott Park, Ill., has received approval of Trilipix (fenofibric acid) delayed-release capsules for use along with diet to help lower triglycerides and LDL and raise HDL in patients with lipid problems.

The FDA has announced new recommendations on evaluating cardiovascular (CV) risk of drugs intended to treat type 2 diabetes, asking manufacturers to provide evidence that the therapy will not increase the risk of heart attacks and other events.

Degarelix, an injectable treatment for advanced prostate cancer manufactured for Ferring Pharmaceuticals Inc., Parsippany, N.J., by Rentschler Biotechnologie Gmbh, Laupheim, Germany, has won approval from the FDA.