Alembic Pharma gets USFDA nod for breast cancer drug

The drug maker said that it has received a final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Faslodex Injection, 250 mg/5 mL (50 mg/mL), of AstraZeneca Pharmaceuticals LP.

Fulvestrant Injection is an estrogen receptor antagonist indicated for the treatment of breast cancer.

According to IQVIA, Fulvestrant Injection has an estimated market size of $71 million for twelve months ending September 2022.

The pharmaceutical company said that it has received a cumulative total of 179 ANDA approvals (156 final approvals and 23 tentative approvals) from USFDA.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.

On consolidated basis, the company's net profit declined 18.7% to Rs 133.35 crore despite of 14.1% jump in revenue from operations to Rs 1,475.01 crore in Q2 FY23 over Q2 FY22.

Shares of Alembic Pharmaceuticals rose 0.95% to Rs 587.10 on the BSE.

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