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Product History
1986
 | Genzyme markets 32 research reagents or diagnostic intermediates (20 manufactured in Kent, U.K.) for use in laboratory analysis.
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 | Introduces InterTest-2, the industry’s first in vitro test kit that uses monoclonal antibodies to measure human interleukin-2.
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 | Hyaluronic acid (HA) and glucocerebrosidase (GCR) enter clinical trials. |
1988
 | U.S. Food and Drug Administration (FDA) approves the marketing of clindamycin phosphate, an antibiotic used to treat serious hospital infections. |
1989
 | Genzyme is allowed to make Ceredase® (alglucerase injection) available to seriously ill patients prior to marketing approval.
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 | IG Labs is first to begin testing for the first cystic fibrosis mutation. |
1990
 | Ceredase becomes available to patients outside the United States on a named-patient basis. |
1991
 | FDA grants marketing approval for Ceredase.
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 | Alcon receives FDA approval to market Provisc®, a Genzyme-developed HA-based opthalmic product.
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 | IG Labs introduces Insight®, a prenatal cytogenetic test. |
1992
 | Israeli Ministry of Health approves Ceredase. |
1993
 | Genzyme Diagnostics begins marketing its direct LDL cholesterol kit.
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 | Begins marketing Predicta erythroproietin ELISA kit for the diagnosis of anemia. |
1994
 | FDA grants marketing approval of Cerezyme.
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 | Ceredase is approved for marketing in Germany, Australia, France, Holland, and the U.K. |
1995
 | Ceredase receives reimbursement approval in Brazil and is approved for marketing in Portugal, Italy, New Zealand, Sweden, and Spain. |
1996
 | Genzyme launches Seprafilm™ adhesion barrier in Europe.
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 | Ceredase receives marketing approval in Japan.
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 | FDA grants approval to market Seprafilm for use in open abdominal or pelvic surgery.
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 | Genzyme Diagnostics begins marketing N-geneous HDL cholesterol test in the United States. |
1997
 | Marketing approval of Seprafilm in Japan; product co-marketed with Kaken Pharmaceutical Co., Ltd., Tokyo.
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 | Genzyme Genetics introduces Afp4SM, a more accurate biochemical screening test for Downs Syndrome.
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 | FDA issues a biologics license application for Carticel® (autologous cultured chondrocytes) to repair cartilage in the knee — the first for a cell therapy product. |
1998
 | FDA grants U.S. marketing approval for Renagel® (sevelamer hydrochloride) and Thyrogen® (thyrotropin alfa for injection).
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 | FDA grants marketing approval for Synvisc® (hylan G-F 20).
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 | FDA grants marketing approval for Thymoglobulin® (anti-thymocyte globulin). |
1999
 | Thyrogen® approved for use in the 15 member states of the European Union.
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 | FDA approves WelChol™ (colesevelam hydrochloride) for marketing.
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 | Genzyme receives the European CE Mark for Seprafilm for use in reducing adhesions following cardiac surgery.
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 | Partners Genzyme and Biogen receive Orphan Drug Designation for AVONEX® (interferon beta 1-a) in Japan. |
2000
 | Genzyme Genetics introduces the 87-mutation cystic fibrosis test, the most comprehensive on the market.
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 | Genzyme receives registration approval of Thyrogen in Brazil.
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 | Genzyme granted marketing approval of Renagel Capsules in the European Union.
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 | Genzyme receives marketing approval for Sepramesh™ Biosurgical Composite for use in hernia repair procedures.
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 | Genzyme obtains rights to develop and commercialize Synpac’s CHO-based enzyme replacement for Pompe disease. |
2001
 | Genzyme launches Fabrazyme® (afgalsidase beta for injection) in the European Union.
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 | With partner Cambridge Antibody Technology, begins phase 1-2 clinical trial of human anti-TGF-beta monoclonal antibody for the treatment of scleroderma. |
2002
 | Genzyme receives approval for Thyrogen in Canada.
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 | European Union approves Synvisc for use in the hip.
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 | Genzyme Oncology begins kidney cancer clinical trial. |
2003
 | Genzyme begins enrolling patients in multiple Pompe Disease studies to support rapid development and approval of Myozyme™.
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 | FDA approves Genzyme’s Fabrazyme, the first treatment approved in the United States for people suffering from Fabry disease, with orphan drug status.
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 | Genzyme and partner BioMarin receive FDA approval of Aldurazyme, the first specific treatment approved for people with mucopolysaccharidosis I (MPS I).
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 | Genzyme and Dyax announce joint venture for DX-88 in Hereditary Angioedema.
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 | Europe expands Cerezyme label to include Type 3 Gaucher Disease.
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 | Genzyme files to market Synvisc in Japan.
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 | Genzyme receives extended European label for Thyrogen. |
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