FDA Approves First Generic Capecitabine to Treat Colorectal and Breast Cancers
The US Food and Drug Administration today approved the first generic version of Xeloda (capecitabine), an oral chemotherapy pill used to treat cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic), and metastatic breast cancer.
New Medical Device Treats Urinary Symptoms Related to Enlarged Prostate
The US Food and Drug Administration today authorized the marketing of the UroLift system, the first permanent implant to relieve low or blocked urine flow in men age 50 and older with an enlarged prostate.
GE Pharma Announces a Recall of Dietary Supplement Creafuse Powder
Ge Pharma, LLC of North Haven, CT is recalling Creafuse Powder Grape Lot# GE4568 and Creafuse Powder Fruit Punch Lot #GE4570, packaged in a white, 600 gram container with an expiration date of 2/2015 because it contains 1,3 dimethylamylamine (DMAA).
Leiters Compounding Pharmacy Issues Voluntary Nationwide Recall of Three Product Lots
Leiter's Compounding Pharmacy is voluntarily recalling 3 lots of its sterile products due to concerns of sterility assurance with Front Range Laboratories, Leiter's Compounding Pharmacy's independent testing laboratory. 
FDA Approves Botox Cosmetic to Improve the Appearance of Crows Feet Lines
The US Food and Drug Administration today approved a new use for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe lateral canthal lines, known as crow’s feet, in adults.
Park Compounding is Voluntarily Recalling One Lot of Sterile Medication
Park Compounding is voluntarily recalling one lot of sterile medication Testoserone Cypionate (Sesame Oil) 200mg/ml Lot #05072013@1 Exp: 11/3/2013 for injection in 10ml amber vials, to the consumer level.
FDA Announces Safety Labeling Changes and Postmarket Study Requirements for Extended-Release and Long-Acting Opioid Analgesics
The US Food and Drug Administration today announced class-wide safety labeling changes and new postmarket study requirements for all extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain.
Avella Specialty Pharmacy Issues Voluntary Nationwide Recall of Two Medications
Avella Specialty Pharmacy is voluntarily recalling two compounded sterile medications. The recall is a result of concerns of sterility assurance with the specialty pharmacy’s independent testing laboratory, Front Range Laboratories.
Medaus Pharmacy Initiates a Nationwide Recall of Certain Pharmacy Products
Medaus Pharmacy is voluntarily recalling certain sterile compounded consumer products due to their inability to confirm that the quality control testing performed on these specific lots by an independent, third party laboratory was conducted in a manner consistent with the highest standards of excellence they demand from themselves and on behalf of their patients.
FDA Investigating Rare Brain Infection in Patient Taking Gilenya (fingolimod)
The US Food and Drug Administration (FDA) is alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a rare and serious brain infection after taking the drug Gilenya (fingolimod).
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