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://www.yalepharmaceuticals.com/Products/PrescriptionDrug...
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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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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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Hyaluronidase - Wikipedia, the free encyclopedia
18 Oct 2009 ... Brand names of animal-derived hyaluronidase include HydaseTM (developed and manufactured by PrimaPharm Inc., distributed by Akorn Inc.) ...
http://en.wikipedia.org/wiki/Hyaluronidase...
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Clinical
... animalderived products AmphadaseTMAmphastar Pharmaceuticals Rancho Cucamonga CA is a bovinecow derivative HydaseKeystone Pharmaceuticals Laguna Hills CA ...
http://www.ons.org/about/FAQ/Clinical/...
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Controversies in Drug Substitution: Follow-on Biologics Introduce ...
... hyaluronidase recombinant human (Hylenex), hyaluronidase (Hydase and Amphadase), and calcitonin salmon recombinant (Fortical) nasal spray. ...
http://www.medscape.com/viewarticle/563959_5...
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Clinical
Three are animal-derived products: AmphadaseTM (Amphastar Pharmaceuticals, Rancho Cucamonga, CA) is a bovine (cow) derivative; Hydase (Keystone ...
http://www.ons.org/about/FAQ/Clinical...
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