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news.Roxane Laboratories, a subsidiary of Boehringer Ingelheim, has received approval from the FDA for its abbreviated new drug application (ANDA) for Anastrozole tablets of strength 1mg.
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Anastrozole is an aromatase inhibitor, which interrupts a critical step in the body’s synthesis of estrogen. Some breast cancer cells require estrogen to grow, and eliminating estrogen suppresses their growth.
Roxane Laboratories said that the product is now made available in bottles of 30 for immediate shipment to wholesalers and pharmacies.
Roxane Laboratories claimed that its Anastrozole tablets are AB rated to Arimidex (anastrozole) tablets, a product of AstraZeneca.
Arimidex (anastrozole) is an aromatase inhibitor indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer; first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer and treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.