Alembic Pharmaceuticals receives USFDA Final Approval for Deferasirox Tablets, 180 mg

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Deferasirox Tablets, 180 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Jadenu Tablets, 180 mg, of Novartis Pharmaceuticals Corporation (Novartis). Deferasirox tablets are indicated for treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) and for treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes. Alembic had previously received final approval for Deferasirox Tablets, 90 mg and 360 mg and tentative approval for Deferasirox Tablets, for 180 mg.

Deferasirox Tablets, 180 mg have an estimated market size of US$ 53 million for twelve months ending March 2020 according to IQVIA.

Alembic now has a total of 122 ANDA approvals (109 final approvals and 13 tentative approvals) from USFDA.

Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.890 as compared to the previous close of Rs. 853.95. The total number of shares traded during the day was 40901 in over 3823 trades.

The stock hit an intraday high of Rs. 899.5 and intraday low of 850. The net turnover during the day was Rs. 36098038.

Source : Equity Bulls

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