Alembic Pharmaceuticals receives USFDA Final Approval for Fulvestrant Injection

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received 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 SingleDose 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. Refer to our label for full indication.

Fulvestrant Injection, 250 mg/5 mL, has an estimated market size of US$71 million for twelve months ending Sep 2022 according to IQVIA.

Alembic has received a cumulative total of 179 ANDA approvals (156 final approvals and 23 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 581.60 as compared to the previous close of Rs. 588.65. The total number of shares traded during the day was 6095 in over 690 trades.

The stock hit an intraday high of Rs. 600.00 and intraday low of 575.80. The net turnover during the day was Rs. 3593490.00.

Source : Equity Bulls

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AlembicPharmaceuticals INE901L01018 USFDA FinalApproval ANDA FulvestrantInjection