Analgesic Okayed for Relief of Chronic Pain
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.
All articles by William Weber
Safety Review on Cholesterol-Lowering Drugs Updated
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.
IND Application for Conjugate to Fight RCC Advances
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.
Blood Glucose Monitoring System Approved
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.
Topical Gel for Overactive Bladder Approved
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.
New Data Needed on Anemia Drug for CKD Patients
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.
Fibrate Cleared to Manage Cholesterol in Combo with Statin
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.
New Recommendations on Evaluating CV Risk of Diabetes Drugs
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.
Injectable Drug for Advanced PCa Approved
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.
Analgesic for Acute Pain Okayed
The FDA has approved tapentadol hydrochloride, an immediate-release oral tablet in doses of 50, 75, or 100 mg for the relief of moderate-to-severe acute pain.
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