US food and drug administration approval of generic versions of complex biologics: Implications for the practicing physician using low molecular weight heparins

Journal of Thrombosis and Thrombolysis

Volumn 33, Issue 3, 2012, Pages 230-238

  Cohen, Marc ^a   Jeske, Walter P ^b   Nicolau, Jose C ^c   Montalescot, Gilles ^d   Fareed, Jawed ^b  

^a NEWARK BETH ISRAEL MEDICAL CENTER   (United States)

^b LOYOLA UNIVERSITY CHICAGO   (United States)

^c UNIVERSITY OF SÃO PAULO   (Brazil)

^d PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

Author keywords

Anticoagulant; FDA; Generics; Low molecular weight heparin

Indexed keywords

ANTICOAGULANT AGENT; ANTITHROMBIN; CLOPIDOGREL; DALTEPARIN; DISACCHARIDE; ENOXAPARIN; GENERIC DRUG; HEPARIN; LOW MOLECULAR WEIGHT HEPARIN; PROPOFOL; REFERENCE LIST DRUG; TINZAPARIN; UNCLASSIFIED DRUG; BIOLOGICAL PRODUCT;

ACUTE CORONARY SYNDROME; ANGINA PECTORIS; ANTICOAGULATION; ARTICLE; BIOEQUIVALENCE; BIOPHYSICS; BIOSIMILAR; BLEEDING; CELL ACTIVATION; CHEMICAL COMPOSITION; CLINICAL PRACTICE; DEPOLYMERIZATION; DRUG APPROVAL; DRUG COST; DRUG DISTRIBUTION; DRUG EFFECT; DRUG EFFICACY; DRUG MEGADOSE; DRUG POTENCY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HEART INFARCTION; HEPARIN INDUCED THROMBOCYTOPENIA; HUMAN; IMMUNOGENICITY; IN VIVO STUDY; NONHUMAN; PHARMACODYNAMICS; PHYSICIAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; SIDE EFFECT; UNITED STATES; ANIMAL; METHODOLOGY; PHYSICIAN ATTITUDE; REVIEW; STANDARD;

ANIMALS; BIOLOGICAL AGENTS; DRUG APPROVAL; DRUGS, GENERIC; HEPARIN, LOW-MOLECULAR-WEIGHT; HUMANS; PHYSICIAN'S ROLE; PRACTICE GUIDELINES AS TOPIC; UNITED STATES;

EID: 84869410273     PISSN: 09295305     EISSN: 1573742X     Source Type: Journal    
DOI: 10.1007/s11239-012-0680-3     Document Type: Article

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