The North American Metal Packaging Alliance, Inc. (NAMPA) supports the U.S. Food and Drug Administration’s (FDA) announcement today to continue its ongoing scientific research and evaluation of bisphenol A (BPA). At the same time, FDA officials reiterated that consumers can continue to use safely existing products that contain BPA. The FDA announcement clearly noted that BPA exposure is not proven to harm children or adults which is consistent with other international regulatory bodies.

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The U.S. Food and Drug Administration has approved Cymbalta® (duloxetine HCl) for the maintenance treatment of generalized anxiety disorder (GAD) in adults, Eli Lilly and Company announced. The efficacy and safety of Cymbalta for the maintenance treatment of GAD were established in a double-blind, placebo-controlled trial. Patients with GAD who initially had responded to treatment with Cymbalta 60-120 mg/day during a 26-week open-label phase were randomly assigned to receive Cymbalta 60-120mg/day or placebo.

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Covidien, a US-based provider of healthcare products, and Nuvo Research, a Canadian drug development company, have received the FDA’s approval of its new drug application for Pennsaid topical solution 1.5% w/w. Pennsaid topical solution is a non-steroidal anti-inflammatory drug (NSAID) used for the treatment of the signs and symptoms of osteoarthritis of the knee. Covidien is responsible for all US commercialization activities, and is responsible for the clinical development of Pennsaid Plus.

Eurand N.V., a specialty pharmaceutical company, has announced U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for Zenpep (pancrelipase) Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions. Zenpep is the only FDA-approved pancreatic enzyme product (PEP) that has been evaluated in clinical studies in adults and children.

The FDA has approved Arzerra for the treatment of patients with chronic lymphocytic leukemia (CLL) that is refractory to fludarabine and alemtuzumab. Arzerra is a monoclonal antibody that causes the body’s immune response to fight against normal and cancerous B-cells. Arzerra attaches to the small and large loop epitopes on a molecule called CD20, which is found on the surface of B-cells, the type of cell which becomes cancerous in CLL.

Talecris Biotherapeutics has received approval from the Food and Drug Administration (FDA) for PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human]), a more concentrated version of PROLASTIN® produced using advances in manufacturing technology. PROLASTIN-C is indicated for the treatment of alpha1-antitrypsin (AAT) deficiency, a genetic condition in which low levels of this essential protein can result in emphysema. The active protein in PROLASTIN-C increases or “augments” protein levels in AAT-deficient patients at risk for developing emphysema.

Leafy greens, tomatoes, even sprouts are among the ten foods that pose the biggest risks of food poisoning, according to a new report from the nonprofit Center for Science in the Public Interest. These 10 foods account for roughly 40% of all food borne outbreaks linked to FDA-regulated food, the report found. Leafy greens top the list, followed by eggs and tuna. While cheese came in at the sixth position, berries, which are loaded with antioxidants, were tenth on the list.

Dyadic International Inc has received approval from the FDA for the use of its C1-derived cellulase enzyme. The enzyme is derived from a genetically modified strain of its patented C1 organism and is used in the fermentation of wine, beer and fruit juices. The approval is known as a “GRAS,” which acknowledges that the product is safe to use in its intended conditions of use.

The U.S. Food and Drug Administration has granted full approval to Eisai Corporation’s ONTAK(R) (denileukin diftitox) solution to be used in the form of an intravenous injection for treating patients suffering from recurrent cutaneous T-cell lymphoma (CTCL) . The supplemental biologics license application is based on findings of a Phase III clinical trial that measured the efficacy of ONTAK in patients with this rare form of malignant lymphoma.

The U.S. Food and Drug Administration has granted 510(k) clearance to Applied Biosystems Inc.’s new 7500 Fast Dx Real-Time PCR Instrument for use in conjunction with the new CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel from the U.S. Centers for Disease Control and Prevention. The novel CDC diagnostic assay, along with the 7500 Fast RT- PCR Instrument, is designed to set standards of precision and specificity of diagnostic results for influenza virus testing in the United States. This new test has the power to detect viruses accurately and quickly.