USFDA nod to Alembic Pharma breast cancer injection Fulvestrant
Fulvestrant Injection is an estrogen receptor antagonist indicated for the treatment of breast cancer.;
Vadodara: Drugmaker, Alembic Pharmaceuticals Limited, today announced that the company has received finalapproval from the US Food & Drug Administration (USFDA) for its Abbreviated NewDrug Application (ANDA), Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per SingleDose Prefilled Syringe.
The approved ANDA is therapeutically equivalent to thereference listed drug product (RLD), Faslodex Injection, 250 mg/5 mL (50 mg/mL), ofAstraZeneca Pharmaceuticals LP.
Fulvestrant Injection is an estrogen receptorantagonist indicated for the treatment of breast cancer.
Breast cancer arises in the lining cells (epithelium) of the ducts (85%) or lobules (15%) in the glandular tissue of the breast. Initially, the cancerous growth is confined to the duct or lobule ("in situ") where it generally causes no symptoms and has minimal potential for spread (metastasis). Breast cancer is not a transmissible or infectious disease. Unlike some cancers that have infection-related causes, such as human papillomavirus (HPV) infection and cervical cancer, there are no known viral or bacterial infections linked to the development of breast cancer.
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