On Monday, Alembic Pharmaceuticals said that the US health agency had given its generic Fulvestrant injectable, which is used to treat breast cancer, its final approval.
The approval granted by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA), Fulvestrant injection of strength 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, the company said in a statement.
The approved injection is therapeutically equivalent to the reference listed drug product (RLD), Faslodex Injection, of AstraZeneca Pharmaceuticals LP, it added.
Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of breast cancer, the company said. Fulvestrant injection, 250 mg/5 mL, had an estimated market size of USD 71 million for the 12 months ending September 2022, according to the company, citing IQVIA data.
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With inputs from Agencies.
