Bio Product Guide » FDA

NAMPA: FDA Reaffirms That Current Uses Of BPA Pose No Risk; Calls For More BPA Research

Jim Marino — Mon, 18 Jan 2010 15:37:54 +0000

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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FDA Approves ACTEMRA(R) (tocilizumab) For The Treatment Of Moderately To Severely Active Rheumatoid Arthritis

Jim Marino — Tue, 12 Jan 2010 06:19:46 +0000

Genentech, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved ACTEMRA® (tocilizumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. ACTEMRA is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved to treat RA, and may be used alone or in combination with methotrexate or other disease modifying anti-rheumatic drugs.

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FDA Approves Cymbalta(R) For Maintenance Treatment Of Generalized Anxiety Disorder

Jim Marino — Mon, 04 Jan 2010 10:55:50 +0000

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 and Nuvo Research get FDA approval for osteoarthritis drug

Jim Marino — Tue, 24 Nov 2009 12:20:13 +0000

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 Receives FDA Approval for Zenpep

Jim Marino — Tue, 17 Nov 2009 15:20:17 +0000

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.

Arzerra receives FDA approval

Jim Marino — Tue, 27 Oct 2009 05:11:38 +0000

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.

FDA approves Talecris Biotherapeutics PROLASTIN-C

Jim Marino — Tue, 20 Oct 2009 07:08:26 +0000

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.

Report says greens can also pose health risk

Jim Marino — Tue, 13 Oct 2009 05:30:03 +0000

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 receives FDA approval for cellulase enzyme

Jim Marino — Tue, 06 Oct 2009 04:05:54 +0000

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.

FDA nod to Eisai’s ONTAK solution

Jim Marino — Fri, 17 Oct 2008 05:36:55 +0000

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.