Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today announced the launch of the generic equivalent to Gleevec®1(imatinib mesylate) tablets,100 mg and 400 mg, in the United States for multiple indications approved by the FDA.
Teva remains committed to strengthening its generics business with continued investment in new and diverse, high quality products. With nearly 375 generic medicines available, Teva has one of the largest portfolios of FDA-approved generic products on the market. The addition of this product to Teva’s oncology portfolio allows Teva to continue to grow in this therapeutic area.
Imatinib mesylate tablets had annual sales of approximately $2.42 billion in the United States, according to IMS data as of May 2016.
About Imatinib Mesylate Tablets
Imatinib mesylate tablets are indicated for: newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase; patients with Ph+ CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy; adult patients with relapsed or refractory Philadelphiachromosome positive acute lymphoblastic leukemia; adult patients with myelodysplastic/myeloproliferative diseases associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements; adult patients with aggressive systemic mastocytosis without the D816V c-Kit mutation or with c-Kit mutational status unknown; adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown; adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans; and adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive gastrointestinal stromal tumors (GIST) .
Important Safety Information
Serious adverse reactions associated with imatinib mesylate treatment include: edema and severe fluid retention; anemia, neutropenia, and thrombocytopenia; severe congestive heart failure and left ventricular dysfunction; severe hepatotoxicity, including fatalities; Grade 3/4 hemorrhage in patients with newly diagnosed CML and with GIST; gastrointestinal perforations, including fatalities; cardiogenic shock/left ventricular dysfunction in patients with conditions associated with high eosinophil levels; bullous dermatologic reactions, including erythema multiforme and Stevens-Johnson syndrome; hypothyroidism in thyroidectomy patients undergoing levothyroxine replacement; fetal harm when administered to a pregnant woman; growth retardation in children and pre-adolescents; and tumor lysis syndrome, including fatalities.
Reports of motor vehicle accidents have been received in patients receiving imatinib mesylate. Patients may experience dizziness, blurred vision or somnolence during treatment with imatinib mesylate. The most frequently reported adverse reactions (≥ 30%) for imatinib mesylate in clinical trials were: edema, nausea, vomiting, muscle cramps, musculoskeletal pain, diarrhea, rash, fatigue, and abdominal pain.
Filed Under: Drug Discovery