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Mylan Pharmaceuticals has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Erlotinib Hydrochloride Tablets, 25 mg, 100 mg and 150 mg, and the product has been launched in the United States market. This product is a generic version of Genentech’s Tarceva.
Erlotinib hydrochloride tablets are indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) 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 1 prior chemotherapy regimen.