BREAST CANCER DRUG GRANTED ADDITIONAL SIX MONTHS OF PATENT PROTECTION

From Drugtopics.com

Anastrozole (Arimidex, AstraZeneca) has been granted an additional six months of patent protection by the FDA under the agency's pediatric exclusivity rule. The change came after the manufacturer performed clinical trials examining the use of anastrozole in children. Interestingly, the patent extension was still granted despite the fact that no therapeutic potential was found for anastrozole in the pediatric population and AstraZeneca will not seek an approval for an indication in children. Currently, anastrozole is approved for use in adults as first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer, for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer, and for treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.