CAMBRIDGE, Mass.–(BUSINESS WIRE)–Genzyme Corporation (Nasdaq: GENZ) today appear that the FDA’s Orthopaedic and Rehabilitation Devices Advising Board voted absolutely (5 – 0) in favor of approval afterwards altitude of Synvisc-One™ (hylan G-F 20). The board fabricated this assurance based on the analytic balloon after-effects Genzyme submitted to abutment the Premarket Approval (PMA) appliance supplement for Synvisc-One, an another assay dieting for Genzyme’s Synvisc® that contains the aforementioned absolute and absolute assay volume, but provides the 6 mL of hylan G-F 20 in a distinct injection. Synvisc-One is brash for the abatement of affliction associated with osteoarthritis (OA) of the knee.
The Advising Board additionally bent the following:
The FDA will now appraise the committee’s ascribe and accomplish a assurance about the aing accomplish against approval of Synvisc-One. Formal activity is accepted on Genzyme’s PMA by December 23, 2008.
Genzyme Senior Vice President Alison Lawton said, “Genzyme appreciates the ascribe of the advising board and we are admiring that they accurate the approval of what will be the alone distinct bang viscosupplement assay accessible to OA patients. We attending avant-garde to alive with FDA to actuate the best active aisle against approval of Synvisc-One.”
Synvisc-One has already been accustomed in the European Union and a cardinal of Asian and Latin American countries. About 10,000 patients accept been brash with Synvisc-One back it was aboriginal accustomed aftermost year.
Synvisc is adumbrated for the assay of affliction due to osteoarthritis (OA) of the knee in patients who accept bootless to acknowledge abundantly to bourgeois nonpharmacologic analysis and simple analgesics, for example, acetaminophen. Synvisc is currently accustomed in Europe and Canada to amusement affliction due to osteoarthritis in the knee and hip, and additionally accustomed in Europe for the abate and accept indications, accoutrement the above joints.
In analytic trials, the best frequently appear adverse contest were brief bounded pain, swelling, and/or address in the injected knee. In some cases, these affection accept been extensive. Added ancillary furnishings such as adventurous accept been appear rarely. Synvisc is contraindicated in patients with accepted hypersensitivity to hyaluronan articles or patients with infections in or about the knee. Healthcare practitioners should exercise attention back application Synvisc in patients allergic to aerial proteins, feathers, or egg products; who accept affirmation of venous or aqueous antithesis in the leg to be treated; or who accept astringent deepening in the knee collective to be treated. Patients should be brash to abstain arduous or abiding weight-bearing activities afterwards treatment. Strict adherence to antibacterial address charge be followed to abstain collective infection. The assurance and capability of Synvisc in accouchement and in abundant or lactating women accept not been established. It is alien whether Synvisc is excreted in animal milk.
One of the world’s arch biotechnology companies, Genzyme is committed to authoritative a above absolute appulse on the lives of bodies with austere diseases. Back 1981, the aggregation has developed from a baby start-up to a adapted action with added than 10,000 advisers in locations spanning the apple and 2007 revenues of $3.8 billion. In 2007, Genzyme was called to accept the National Medal of Technology, the accomplished account awarded by the President of the United States for abstruse innovation.
With abounding accustomed articles and casework allowance patients in about 90 countries, Genzyme is a baton in the accomplishment to advance and administer the best avant-garde technologies in the activity sciences. The company’s articles and casework are focused on attenuate affiliated disorders, branch disease, orthopaedics, cancer, displace and allowed disease, and analytic testing. Genzyme’s charge to addition continues today with a abundant development affairs focused on these fields, as able-bodied as cardiovascular disease, neurodegenerative diseases, and added areas of unmet medical need.
Genzyme’s columnist releases and added aggregation advice are accessible at www.genzyme.com and by calling Genzyme’s broker advice band at 1-800-905-4369 aural the United States or 1-678-999-4572 alfresco the United States.
This columnist absolution contains advanced statements about Genzyme’s approaching affairs and strategies, including Genzyme’s apprehension that the FDA will act on its PMA by December 23, 2008. Avant-garde attractive statements are accountable to risks and uncertainties that could account absolute after-effects to alter materially from those projected. These risks and uncertainties include, amid others: whether the FDA determines that Synvisc-One can appropriately be accustomed for business in the US and whether it makes such assurance by December 23rd; and the risks and uncertainties declared in letters filed by Genzyme with the U.S. Securities and Exchange Commission, including afterwards limitation the factors discussed beneath the explanation “Risk Factors” in Genzyme’s Quarterly Report on Form 10-Q for the budgetary division concluded September 30, 2008. We attention investors not to abode disproportionate assurance on the advanced statements independent in this columnist release. These statements allege alone as of the date of this columnist release, and we undertake no obligation to amend or alter the statements.
Genzyme® and Synvisc® are registered trademarks and Synvisc-One™ is a brand of Genzyme Corporation or its subsidiaries. All rights reserved.
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