Orthopedic Product Guide » FDA

ArthroCare Receives FDA Clearance For Parallax Contour Vertebral Augmentation Device

Josie Rich — Wed, 29 Sep 2010 14:18:47 +0000

ArthroCare Corp. announced that it has received clearance from the FDA to market its Parallax® Contour® Vertebral Augmentation Device (Contour) specifically for void creation in a vertebral body followed by injection of bone cement. Vertebral body void creation followed by bone cement augmentation is commonly used to treat painful vertebral compression fractures. The newly cleared Indication Statement provides that the Contour device is indicated for use during kyphoplasty or vertebral augmentation procedures.

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Studies Link PPIs To Increased Risk Of Fracture

Josie Rich — Wed, 07 Jul 2010 18:31:53 +0000

Revised labeling for prescription and over-the-counter proton pump inhibitors (PPIs) will warn that these stomach acid–reducing medications could increase patients’ risk of hip, wrist, and spine fractures, US health authorities announced. The FDA’s decision to add new precautionary information to PPI labeling is based on data from 7 epidemiological studies published since 2006. Six of the 7 showed a relationship between PPI use and an increased risk of fractures. Most of the patients in the studies were aged 50 years or older; the increased risk of fracture was seen primarily in this group.

FDA Accepts PMA Application for Augment Bone Graft

Josie Rich — Wed, 07 Jul 2010 18:26:41 +0000

BioMimetic Therapeutics Inc announced that the US Food & Drug Administration (FDA) has accepted for review its Premarket Approval (PMA) application for Augment Bone Graft for use in foot and ankle fusions in the US. The FDA has now filed the application and begun the comprehensive review of the clinical module, the company added.

FDA Accepts PMA Application for Augment Bone Graft

BioMimetic Therapeutics, Inc announced that the US Food & Drug Administration (FDA) has accepted for review its Premarket Approval (PMA) application for Augment Bone Graft for use in foot and ankle fusions in the US. The FDA has now filed the application and begun the comprehensive review of the clinical module, the company added.

Pfizer Suspends Tanezumab Osteoarthritis Clinical Trial Program

Josie Rich — Thu, 01 Jul 2010 14:43:44 +0000

Pfizer Inc. has announced the suspension of the osteoarthritis clinical program for the investigational compound tanezumab following a request by the U.S. Food and Drug Administration (FDA). The worldwide suspension which is effective immediately follows a small number of reports of tanezumab patients experiencing the worsening of osteoarthritis leading to joint replacement. To date, this adverse event has not been observed in non-osteoarthritis patient populations taking tanezumab.

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New Injectable Osteoporosis Drug Prolia Gains FDA Approval

Josie Rich — Fri, 11 Jun 2010 13:19:33 +0000

Prolia, a new injectable drug to treat osteoporosis in postmenopausal women at high risk of fractures has been approved by the US Food and Drug Administration (FDA).The federal agency has announced that approving Prolia, made by Amgen, offers postmenopausal women with osteoporosis at high risk of fractures another treatment option. Osteoporosis is a disease that weakens bone and makes it more likely to break.

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The FDA Okays Rheumatoid Arthritis Treatment Actemra

Josie Rich — Thu, 28 Jan 2010 05:47:29 +0000

The FDA has approved the drug to treat rheumatoid arthritis, Actemra, the only product on the market that will actively prevent this inflammatory process at the source. Although there are 9 biologically designed products on the market that will treat certain forms of arthritis, Actemra is the only drug that is targeting the disease at the molecular level.

Actemra prevent the arthritis by effectively halting the processing ability of a specific molecular protein known as Interleukin 6 which is known to cause inflammation in the bones and joints of the human body.

Approval of Denosumab may be delayed

Josie Rich — Thu, 22 Oct 2009 15:22:17 +0000

Denosumab, a potential game-changer for Amgen Inc, is expected to be the most notable launch in the biotech industry in years. However, many on Wall Street expect the FDA’s approval decision to be delayed by about three months from the expected date of October 19 because the agency has a history of missing deadlines and may want more time to analyze the safety record of a new drug like denosumab.

FDA to decide on Xiaflex shortly

Josie Rich — Thu, 15 Oct 2009 03:25:07 +0000

Auxilium Pharma is awaiting a decision from the FDA on its key pipeline candidate, Xiaflex, for the treatment of Dupuytren’s Contracture. The drug has received favorable recommendation from the FDA’s Arthritis Advisory Committee. Dupuytren’s Contracture is a condition that affects the connective tissue in the palm known as palmar fascia. The company estimates that about 240,000 people suffer from Dupuytren’s in the US and the EU. This represents significant commercial opportunity for Auxilium.

Study: Bone loss drug may also help in cartilage repair

Josie Rich — Thu, 08 Oct 2009 06:14:51 +0000

A recent study, conducted by researchers at University of Rochester Medical Center and presented at the annual meeting of the American Society for Bone and Mineral Research in Denver, indicated that a drug already approved to heal bone loss from osteoporosis may also help to prevent and reverse the damage to cartilage that leads to osteoarthritis. Currently, there are no drugs to treat cartilage loss in osteoarthritis, a condition that’s expected to affect some 50 million Americans by 2020. Parathyroid hormone, sold as the prescription drug teriparatide (Forteo), is already approved by the FDA to maintain and heal bone, and earlier studies have suggested that it also affects cartilage cells.

First Ceramic-On-Metal Implant for Hip Replacement recommended for approval by FDA advisory panel

Josie Rich — Thu, 10 Sep 2009 04:24:05 +0000

The Orthopaedic and Rehabilitation Devices advisory committee has unanimously recommended the FDA approval of DePuy Orthopaedics’ Pinnacle CoMplete Acetabular Hip System, the first ceramic-on-metal hip bearing to be considered for approval in the US. The recommendation was based on the clinical study comparing Pinnacle CoMplete System to a commonly used DePuy metal-on-metal implant on the efficacy and safety. Laboratory testing on the Pinnacle CoMplete System showed a greater than 90% reduction in wear compared to the metal-on-metal system under normal gait conditions and a more than 80% reduction in wear under adverse conditions.