Teva Launches Generic Gleevec Tablets

Teva’s generic equivalent of Novartis’s Gleevec is now available in the US market.

The generic imatinib mesylate tablets come in 100-mg and 400-mg dosage strengths and are indicated for the following patient populations:

· 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 Ph+ acute lymphoblastic leukemia

· Adult patients with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor (PDGFR) 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)

· 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

· Adjuvant treatment of adult patients following complete gross resection of Kit-positive gastrointestinal stromal tumors

The most frequently reported adverse reactions for imatinib mesylate in clinical trials were edema, nausea, vomiting, muscle cramps, musculoskeletal pain, diarrhea, rash, fatigue, and abdominal pain. Serious adverse reactions include edema and severe fluid retention; anemia, neutropenia, and thrombocytopenia; severe congestive heart failure and left ventricular dysfunction; severe hepatotoxicity, including fatalities; fetal harm when administered to a pregnant woman; growth retardation in children and preadolescents; and tumor lysis syndrome, including fatalities, among others.

There have also been reports of motor vehicle accidents among patients receiving imatinib mesylate. Patients may experience dizziness, blurred vision, or somnolence during treatment.

Imatinib mesylate tablets had US sales of $2.4 billion for the fiscal year ending in May 2016, according to IMS Health data.

Sun Pharma was the first to market a generic version of Gleevec.