Mylan launches generic Tarceva

BY Sandra Levy

Mylan is introducing erlotinib hydrochloride tablets in 25 mg, 100 mg and 150 mg dosage strengths.

The product is the generic of Genentech’s Tarceva and indicated for the treatment of patients with metastatic non-small cell lung cancer.

In addition, it is for those whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.

Erlotinib hydrochloride tablets, 25 mg, 100 mg and 150 mg have a market value of approximately $212 million.


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