Alembic Pharmaceuticals on Monday announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its Fulvestrant injection, which will be used for the treatment of breast cancer.
The clearance has been received from the USFDA for the Abbreviated New Drug Application (ANDA), Fulvestrant injection, 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, the company said in a filing to the exchanges.
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, Alembic Pharma said.
According to IQVIA data, Fulvestrant injection, 250 mg/5 mL, has an estimated market size of $71 million for 12 months ended September 2022.
Alembic has received a cumulative total of 179 ANDA approvals comprising 56 final approvals and 23 tentative clearances from USFDA.
The USFDA has also given it a Prior Approval Supplement (PAS) authorisation for its supplemental ANDA for Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg. Pregabalin capsule is used for the treatment of epilepsy, anxiety and nerve pain.
Shares of Alembic Pharma ended 0.7 percent higher at Rs 584.
