New Delhi: Alembic Pharmaceuticals on Tuesday said it has received final approval from the US health regulator for generic Deferasirox tablets used for treatment of chronic iron overload in patients.
The company has received the final approval from the United States Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Deferasirox tablets in the strength of 180 mg, Alembic Pharmaceuticals said in a BSE filing.
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The company’s product is a generic version of Novartis Pharmaceuticals Corporation’s Jadenu tablets in the same strength, it added. According to IQVIA, Deferasirox tablets, 180 mg, have an estimated market size of USD 53 million for twelve months ending March 2020, Alembic Pharma said.
The tablets are indicated for treatment of chronic iron overload due to blood transfusions and also for chronic iron overload in non-transfusion-dependent thalassemia syndromes, it added.
The company now has a total of 122 ANDA approvals (109 final approvals and 13 tentative approvals) from the USFDA, Alembic Pharma said. Shares of Alembic Pharmaceuticals were trading at Rs 920.50 per scrip on the BSE, up 3.43 per cent over previous close.
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