Latest Biotechnology, Pharmaceutical and Healthcare News from Drugs.com

Methotrexate Sodium, USP Injectable Vials by Sandoz US: Recall - Particulate Matter In Vials

Audience: Pharmacy, Patient, Health Professional ISSUE: Sandoz is conducting a voluntary nationwide recall to the hospital/user level of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the US, due to the...

Abbott Diabetes Care: Class 1 Recall - FreeStyle InsuLinx Blood Glucose Meters - Risk of Incorrect Test Result

Audience: Risk Manager, Patient, Health Professional   [Posted 05/20/2013] ISSUE: Abbott initiated a voluntary recall of FreeStyle lnsulinx Blood Glucose Meters in the United States. At extremely high blood glucose levels of 1024 mg/dL and...

All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance

Audience: Pharmacy, Patient, Health Professional ISSUE: FDA is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA is basing.....

Compounded Prescription Therapies By Pentec Health Inc.: Recall - Lack Of Sterility Assurance

Audience: Pharmacy, Patient, Health Professional   [Posted 05/17/2013] ISSUE: Pentec Health, Inc. initiated a limited, voluntary recall of in-date nutritional prescriptions for renal patients due to lack of sterility assurance associated with.....

FDA Approves Xofigo for Advanced Prostate Cancer

May 15, 2013 -- The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is....

Arbor Pharmaceuticals Announces FDA Approval of Nymalize

May 13, 2013 - Atlanta, GA - Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Nymalize (nimodipine) oral solution. Nymalize was previously granted Orphan...

U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C

RARITAN, N.J., May 13, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for...

FDA Approves Breo Ellipta to Treat Chronic Obstructive Pulmonary Disease (COPD)

May 10, 2013 -- The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive....

Ilaris Approved by FDA to Treat Active Systemic Juvenile Idiopathic Arthritis

Basel, May 10, 2013 - Novartis announced today that the US Food and Drug Administration (FDA) has approved Ilaris (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older. Ilaris is...

Atriphen dietary supplement (Xymogen brand): Recall - Potential Allergic Reaction Due to Milk and Soy

Audience: Consumer, Health Professional ISSUE: The nutraceutical company, Xymogen, (Orlando, FL) and FDA, is notifying consumers and health professionals of the recall of Atriphen, a product sold for the support of healthy joint function, because...

The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products

Audience: Pharmacy, Healthcare Professionals, Patients ISSUE: The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding...

SexVoltz, Velextra, and Amerect by Beomonstar Products: Recall - Undeclared Drug Ingredient

Audience: Consumer ISSUE: BeaMonstar Products notified the public that it is recalling its SexVoltz, Velextra, and Amerect capsules to the retail level. Laboratory analysis conducted by the FDA on SexVoltz and Velextra has determined these products.....

Bullet Proof: Public Notification - Undeclared Drug Ingredient

Audience: Consumer ISSUE: FDA is advising consumers not to purchase or use “Bullet Proof,” a product promoted and sold for sexual enhancement on various websites and in some retail stores. FDA laboratory analysis confirmed that “Bullet...

Lightning Rod Capsules: Recall - Undeclared Drug Ingredient

Audience: Consumer ISSUE: Chang Kwung announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplements sold under the brand name Lightning Rod (500 mg per capsule packaged in 3-count, UPC 6 89076 20257 2 and....

Valproate Anti-Seizure Products: Drug Safety Communication - Contraindicated for Pregnant Women for Prevention of Migraine Headaches

Audience: Health Professional, Neurology, Pharmacy, Patient Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics ISSUE: FDA is advising health...

Kadcyla (ado-trastuzumab emtansine): Drug Safety Communication - Potential Medication Errors Resulting from Name Confusion

Audience: Risk Manager, Pharmacy, Oncology ISSUE: The FDA notified health care professionals that the use of the incorrect nonproprietary name for the breast cancer drug Kadcyla (ado-trastuzumab emtansine) in some medication-related electronic...

FDA Approves Merck’s Liptruzet (ezetimibe and atorvastatin), a New Product That Can Help Lower LDL Cholesterol

Friday, May 3, 2013 - Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Liptruzet (ezetimibe and atorvastatin) tablets for the treatment of elevated low-density...

Bristol-Myers Squibb Receives US FDA sNDA Approval for Use of Sustiva (efavirenz) in HIV-1 Infected Pediatric Patients

Approval offers a once-daily option as part of a regimen for HIV-1 infected infants as young as three months and weighing at least 3.5 kg “Capsule sprinkle” administration allows dosing in patients who cannot swallow capsules...

American Lifestyle Vicerex and Black Ant Capsules: Recall - Undeclared Drug Ingredient

Audience: Consumer ISSUE: May 1, 2013 - American Lifestyle is announcing that it is conducting a voluntary recall of all lots of Vicerex UPC 893490820087 and Black Ant UPC 4026666142546. Laboratory analysis conducted by the FDA has determined the...

FDA Approves Procysbi for Nephropathic Cystinosis

April 30, 2013 -- The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to...

FDA Approves Actemra for Children with Polyarticular Juvenile Idiopathic Arthritis

BASEL, April 30, 2013 -- Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Actemra (tocilizumab) for the treatment of polyarticular juvenile idiopathic arthritis (PJIA). The medicine can be used in children two...

Samsca (Tolvaptan): Drug Safety Communication - FDA Limits Duration and Usage Due To Possible Liver Injury Leading to Organ Transplant or Death

Audience: Pharmacy, Health Professional, Patient ISSUE: FDA has determined that the drug Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver...

Piperacillin and Tazobactam for Injection, USP 40.5 grams: Recall - Precipitation or Crystallization in IV Bag or IV Line Upon Reconstitution

Audience: Risk Manager, Nursing, Health Professional ISSUE: Apotex Corp. notified healthcare professionals it is conducting, on behalf of the manufacturer Hospira, Inc., a voluntary nationwide recall of 15 lots of Piperacillin and Tazobactam for...

Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit By Fenwal: Recall - Labeling Issue Identified

Audience: Risk Manager, Health Professional, Pharmacy [Posted 04/30/2013] ISSUE: Fenwal has initiated a voluntary Urgent Product Recall of one lot (FM13A15027) of product code 4R1584, Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD)...

Potiga (Ezogabine): Drug Safety Communication - Linked To Retinal Abnormalities And Blue Skin Discoloration

AUDIENCE: Health Professional, Neurology, Patient ISSUE: FDA is warning the public that the anti-seizure medication Potiga (Ezogabine) can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina. FDA does...