Generic Gleevec is not FDA approved and will not be until the patent on gleevec expires in 2015.
NATCO an Indian drug company also makes a generic version of Gleevec called Veenat.
Just want to inform all concerned that, in India generic Gleevec is available in the name of "Imatib". It is manufacturing & marketing by famous "CIPLA". Its retail price is only Rs. 300/-, which is around USD $7 per tab. However, Gleevec 400 mg costs Rs. 3000/-, which is around USD $70, or 10 times greater than Imatib
NATCO is also with generic gleevec (Composition-Imatinib Mesylate). Also one or two another Indian Companies are producing generics apart CIPLA. However, I don't know names of these medical Companies and their tablet names. As CIPLA's was recommended by my oncologist as well my cousin, who is a doctor and also CIPLA is very authentic medical Company, I started Imatib. Nothing else. CIPLA's is little costlier than NATCO's.
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Natco Pharma LtdVEENAT (Imatinib Mesylate) is not offered for sale in UK and other countries ... Veenat is offered only to the patients supported by a doctor's prescription ... www.natcopharma.co.in/new.html
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10/15/2009 This abstract just showed up in pubmed this morning. CIPLA is one of the generic brands of imatinib that is made in India. There may be times when some patients are forced to use a generic. If imatinib plasma level testing is available, it would probably be a good idea in these cases.
Failure of a non-authorized copy product to maintain response achieved with imatinib in a patient with chronic phase chronic myeloid leukemia: a case report. Goubran HA.
Professor of Medicine and Clinical Haematology, Faculty of Medicine, Cairo University Maadi, 1431, Cairo Egypt.
INTRODUCTION: Due to high rates of response and durable remissions, imatinib (Glivec((R)), or Gleevec((R)) in the USA; Novartis Pharma AG) is the standard of care in patients with chronic myeloid leukemia. Recently, a non-authorized product which claims comparability to imatinib has become available. CASE PRESENTATION: This report describes the loss of response in a 36-year-old male patient with chronic-phase chronic myeloid leukemia who had previously been in full hematologic and cytogenetic remission and partial molecular remission for three years, under treatment with brand-name imatinib of 400 mg per day. Before the initiation of treatment with a copy product, imatib (CIPLA-India), the patient had negative BCR-ABL status. Within three months of initiation of treatment with the copy product, the patient's BCR-ABL status became positive, with substantial decreases noted in white blood cell counts, red blood cell counts and platelet counts. Conversion of the BCR-ABL status to negative and improvements in hematologic parameters were achieved when the brand medication, imatinib, was resumed at a dose of 600 mg per day. CONCLUSION: In our patient, the substitution of a copy product for imatinib resulted in the rapid loss of a previously stable response, with the risk of progression to life-threatening accelerated phase or blast crisis phase of the disease. Without supportive clinical evidence of efficacy and safety of imatib (or any other copy product) caution should be used when substituting imatinib in the treatment of any patient with chronic myeloid leu
10/31/2009
Bioequivalence of two film-coated tablets of imatinib mesylate 400 mg: A randomized, open-label, single-dose, fasting, two-period, two-sequence crossover comparison in healthy male South American volunteers. Parrillo-Campiglia S, Ercoli MC, Umpierrez O, Rodríguez P, Márquez S, Guarneri C, Estevez-Parrillo FT, Laurenz M, Estevez-Carrizo FE. Clin Ther. 2009 Oct;31(10):2224-2232. PMID: 19922893 [PubMed - as supplied by publisher]
Clin Ther. 2009 Oct;31(10):2224-2232.
Bioequivalence of two film-coated tablets of imatinib mesylate 400 mg: A randomized, open-label, single-dose, fasting, two-period, two-sequence crossover comparison in healthy male South American volunteers. Parrillo-Campiglia S, Ercoli MC, Umpierrez O, Rodríguez P, Márquez S, Guarneri C, Estevez-Parrillo FT, Laurenz M, Estevez-Carrizo FE.
Center for Clinical Pharmacology, Bdbeq S.A., Hospital Italiano Umberto Primo, Montevideo, Uruguay; Center for Biomedical Sciences, University of Montevideo, Montevideo, Uruguay.
Background: Imatinib is a tyrosine kinase inhibitor that has been established as a highly effective therapy for chronic myelogenous leukemia and gastrointestinal stromal tumors. A new generic, once-daily 400-mg tablet of imatinib has been developed by a PHARMACEUTICAL COMPANY in ARGENTINA, where the regulatory standard for marketing authorization of an imatinib generic is in vitro dissolution testing. Objective: The aim of this study was to assess the bioequivalence of a new generic film-coated test tablet formulation versus a film-coated reference tablet formulation of imatinib 400 mg. The local manufacturer seeks to validate the in vitro performance of this new formulation with a bioequivalence study. Methods: A randomized, open-label, single-dose, fasting, 2-period, 2-sequence crossover design with a 2-week washout period was used in this study. The study population consisted of healthy male South American (Uruguayan) volunteers, who were assigned in a 1:1 ratio to a randomized sequence (test-reference or reference-test). In each period, the test or reference formulation was administered after an overnight fast. During the 72-hour follow-up period, participants were monitored for vital signs and symptoms. Blood samples were collected at 15 time points, including baseline, until 72 hours. Physical examination and laboratory tests (blood, urine) were repeated 1 week after study completion. A noncompartmental model was used to determine the pharmacokinetic parameters of imatinib. The 90% CIs of the test/reference ratios for AUC(0-infinity) and C(max) were determined; the test and reference formulations were considered bioequivalent if the 90% CIs were between 0.80 and 1.25. Adverse events were assessed by a nurse who administered a questionnaire while the healthy volunteers were admitted in the unit. Results: The bioequivalence study was conducted in 30 Uruguayan male volunteers. Demographic characteristics (mean [SD]) included age, 27.8 (6.5) years; weight, 71.2 (9.8) kg; height, 1.71 (0.09) m; and body mass index, 24.3 (3.0) kg/m2. The mean (SD) of AUC(0-infinity) was 38,179 (15,504) ng/mL . h(-1) for the test formulation and 40,554 (17,027) ng/mL . h(-1) for the reference formulation. The mean of Cmax for the test formulation was 2472 (933) ng/mL, and the mean Tmax was 3.28 (0.93) hours. The mean of Cmax for the reference formulation was 2566 (963) ng/mL, and the mean T(max) was 3.63 (1.20) hours. The point estimates (90% CIs) for the test/reference ratios of the log-transformed AUC- and C(max) mean values were 0.95 (0.87-1.03) and 0.97 (0.89-1.05), respectively, which met the regulatory criteria for bioequiv-alence. Thirty-four mild to moderate adverse events were reported (13 with the test formulation and 21 with the reference formulation), and no serious or unexpected adverse events were observed during the study. The adverse events included 16 cases of headache, 13 cases of nausea, 4 cases of vomiting, and 1 episode of diarrhea. Conclusions: The results of this study suggest that the test formulation of imatinib met the regulatory criteria for bioequivalence to the reference formulation in these healthy fasting male volunteers. Both formulations were generally well tolerated and appeared to have a similar adverse-event profile.
PMID: 19922893 [PubMed - as supplied by publisher]
November 16, 2009
Sun Pharma gets tentative USFDA nod for Imatinib Mesylate tablets Source: IRIS
Drug maker, Sun Pharmaceutical Industries has been granted tentative approval from United States Food and Drug Administration (USFDA) for Imatinib Mesylate tablets.
The said drug would be available in strengths of 100 mg and 400 mg. The drug is indicated to treat patients following complete removal of a kit positive gastrointestinal stromal tumor (GIST), a rare cancer of the gastrointestinal tract.