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Mylan N.V issued the following announcement on May 10.
Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced the U.S. launch of Erlotinib Hydrochloride Tablets, 25 mg, 100 mg and 150 mg, a generic version of Genentech's Tarceva®. Mylan Pharmaceuticals received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.
Erlotinib Hydrochloride Tablets is indicated for the treatment of patients with metastatic non-small cell lung cancer 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 one prior chemotherapy regimen. The safety and efficacy of erlotinib has not been established in patients with NSCLC whose tumors have other EGFR mutations. It is also indicated as a first-line treatment for patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. Erlotinib is not recommended for use in combination with other platinum-based chemotherapy.
U.S. sales for Erlotinib Hydrochloride Tablets, 25 mg, 100 mg and 150 mg were approximately $212 million for the 12 months ending March 31, 2019, according to IQVIA.
Currently, Mylan has 165 ANDAs pending FDA approval representing approximately $82.2 billion in annual brand sales, according to IQVIA. Forty-six of these pending ANDAs are potential first-to-file opportunities, representing $56.4 billionin annual brand sales, for the 12 months ending December 31, 2018, according to IQVIA.
Original source can be found here.
