Erlotinib Tablets are a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) 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 Tablets are also indicated for first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine.
"The launch of generic Tarceva tablets marks an important addition to our offering of oncology products," said Brendan O'Grady, EVP and Head of North America Commercial.
With nearly 500 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the US.
Currently, one in eight generic prescriptions dispensed in the US is filled with a Teva generic product.
Tarceva tablets have annual sales of USD 202m in the US, according to IQVIA data as of February 2019.
Erlotinib Tablets are indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) 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.
Limitations of use: Safety and efficacy of Erlotinib Tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations. Erlotinib Tablets are not recommended for use in combination with platinum-based chemotherapy.
Erlotinib Tablets in combination with gemcitabine are indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
CivicaScript launches droxidopa for symptomatic neurogenic orthostatic hypotension
Padagis' Naloxone HCl Nasal Spray 4 mg obtains extended shelf-life of 36 months
ANI Pharmaceuticals announces US launch of Nitazoxanide Tablets
Newbury Pharmaceuticals secures approval for Macitentan in Denmark
Mallinckrodt and Endo to merge in USD6.7bn deal to create pharmaceutical leader
Genomma Lab Internacional announces quarterly dividend
Aveva Drug Delivery systems introduces generic Fentanyl Transdermal Patch in US
Independent Pharmacy Cooperative signs cooperation agreement with Legacy Pharmacy Group
ILIKOS Consulting partners with Jordan Center for Pharmaceutical Research
Axsome Therapeutics settles patent litigation with Teva over AUVELITY
Breckenridge Pharmaceutical's Everolimus Tablets for Oral Suspension receive US FDA approval
Newbury Pharmaceuticals secures generic approval for pomalidomide in Denmark
Newbury Pharmaceuticals secures generic approval for Bosutinib in Norway
Guangzhou Fermion Technology partners with Simcere Pharmaceutical