Response to the case report by Mattar: Generic Imatinib (Imatib, Cipla) in a patient with chronic myeloid leukemia in chronic phase

International Journal of Hematology

Volumn 92, Issue 5, 2010, Pages 772-773

  Gogtay, Jaideep ^a   Chahchad, Siddharth ^a   Jadhav, Sonali ^a   Purandare, Shrinivas ^a  

^a CIPLA LTD   (India)

Author keywords

[No Author keywords available]

Indexed keywords

IMATIB; IMATINIB; MESYLIC ACID; UNCLASSIFIED DRUG;

BIOEQUIVALENCE; CHRONIC MYELOID LEUKEMIA; DRUG EFFICACY; DRUG SAFETY; HUMAN; NOTE; QUALITY OF LIFE; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT;

ANTINEOPLASTIC AGENTS; DRUGS, GENERIC; HUMANS; LEUKEMIA, MYELOMONOCYTIC, CHRONIC; PIPERAZINES; PYRIMIDINES; TREATMENT FAILURE;

EID: 78751591443     PISSN: 09255710     EISSN: None     Source Type: Journal    
DOI: 10.1007/s12185-010-0718-2     Document Type: Note

References (5)

1. M Mattar 2010 Failure of copy Imatib (CIPLA, India) to maintain hematologic and cytogenetic responses in chronic myeloid leukemia in chronic phase Int J Hematol 91 104 106 20054670 10.1007/s12185-009-0431-1
2. Guidance for Industry: ANDAs Pharmaceutical Solid Polymorphism. Chemistry, manufacturing and controls information. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. July 2007.
3. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001on the community code relating to medicinal products for Human use. http://www.ema.europa.eu/docs/en-GB/document-library/Regulatory-and-procedural- guideline/2009/10/WC500004481.pdf. Accessed on 10 Nov 2010
4. Data on file, Cipla Ltd, India 2005.
5. Data on file, Cipla Ltd, India 2010.