USFDA nod to Alembic Pharma breast cancer injection Fulvestrant

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.

Fulvestrant Injection, 250 mg/5 mL, has an estimated market size of US$71 million fortwelve months ending Sep 2022 according to IQVIA.Alembic has received a cumulative total of 179 ANDA approvals (156 final approvalsand 23 tentative approvals) from USFDA.

Medical Dialogues team had earlier reported that the company had received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paclitaxel Injection USP, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL) Multiple-Dose Vials.