WARNING LETTER
29 Jun 2006 ... for Hydase by suggesting Hydase is safer than has been demonstrated. ... Hydase™ is indicated as an adjuvant to increase the absorption and ...
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulat...
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Role of hyaluronidase in immediate hypersensitivity reaction.
Hyaluronidase (Hydase) activity in 48-hr homologous passive cutaneous ... Change in Hydase activity correlated well with the increase in capillary ...
http://www.ncbi.nlm.nih.gov/pubmed/6777331...
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CPY Document
Hydase'M, is a preparation of purified bovine testicular .... A preliminary skin test for sensitivity to Hydase'M Can be performed. ...
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulat...
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YalePharma Worldwide
Hydase Hydase(obsolete) Hydeltra-T.B.A.. Hydeltrasol Hydra-Zide hydrALAZINE HydrALAZINE Plus hydrALAZINE-hydrochlorothiazide ...
http://yalepharmaceuticals.com/Products/PrescriptionDrugData...
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PrimaPharm Inc 29-Jun-06
8 Jul 2009 ... Hydase™ is indicated as an adjuvant to increase the absorption and ... The PI also explains that Hydase is associated with several risks. ...
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2...
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Article : Biopharmaceutical Approvals Review Genetic Engineering ...
1 Aug 2006 ... ~Hydase from PrimaPharm (www.primapharm.net) contains ovine (sheep) hyaluronidase and is similar to Vitrase from Amphastar Pharmaceuticals ...
http://www.genengnews.com/articles/chitem.aspx?aid=1838&chid...
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NME Drug and New Biologic Approvals in 2005
30 Apr 2009 ... N021716, Hydase, Hyaluronidase, PrimaPharm, P, 25-Oct-05, Hydase is indicated as an adjuvant to increase the absorption and dispersion of ...
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugs...
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Table 5 : Protein therapeutics: a summary and pharmacological ...
*Hyaluronidase (bovine, ovine), Amphadase (bovine), Hydase (bovine), Vitrase ( ovine), Catalyses the hydrolysis of hyaluronic acid to increase tissue ...
http://www.nature.com/nrd/journal/v7/n1/fig_tab/nrd2399_T5.h...
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Hyaluronidase - Wikipedia, the free encyclopedia
Brand names of animal-derived hyaluronidase include HydaseTM (developed and manufactured by PrimaPharm Inc., distributed by Akorn Inc.) which has been FDA
...
http://en.wikipedia.org/wiki/Hyaluronidase...
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Table 1 : WHO guidelines presage US biosimilars legislation ...
USa, Hyaluronidase, Hydase, PrimaPharm, Approved, November 2005. USa, Recombinant human hyaluronidase, Hylenex, Baxter, Approved, December 2005 ...
http://www.nature.com/nbt/journal/v27/n11/fig_tab/nbt1109-96...
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