On April 18, Qilu Pharmaceutical’s official WeChat account announced that its breast cancer treatment drug, “Exemestane Tablets,” had received approval from the U.S. FDA for market launch. Qilu Pharmaceutical submitted an Abbreviated New Drug Application (ANDA) to the U.S. FDA in May 2019.
Exemestane Tablets took just over 10 months from submission to final approval, passing the formal review and labeling assessment with zero deficiencies, thereby setting the fastest record for the U.S. filing and approval of a generic drug by Qilu Pharmaceutical.
Exemestane Tablets were originally developed by Pfizer and received FDA approval for marketing in 1999. Clinically, they are indicated for the adjuvant treatment of early-stage invasive breast cancer in postmenopausal women with estrogen receptor-positive tumors, following 2–3 years of adjuvant tamoxifen therapy, until completion of a total of 5 years of adjuvant endocrine therapy; and for the treatment of advanced breast cancer in postmenopausal women (either naturally or artificially induced) whose disease has progressed despite prior tamoxifen therapy.
Exemestane Tablets are an effective and selective treatment for postmenopausal hormone-dependent breast cancer. Approved for entry into the Chinese market on December 17, 2008. In 2002, Exemestane Tablets developed by Qilu Pharmaceutical were launched in China, becoming the first domestic product of its kind to reach the market. The product has gained widespread recognition from clinical institutions and patients, currently holding the largest market share among domestically funded enterprises. In May 2019, Qilu Pharmaceutical submitted an application for consistency evaluation, becoming the first and, to date, the only company in China to submit such an application for this product.