VADODARA (BARODA) / MUMBAI / RAJKOT - In a regulatory update as submitted to the Indian Stock Exchanges, Vadodara headquartered Amin family owned 100 years old pharmaceutical products manufacturing Indian company Alembic Pharmaceuticals Ltd said of having got a USFDA (US Food & Drugs Administration) nod to sell medicine to treat chronic iron overload in human blood and further cure the blood disorders.
In a press-release titled, "Alembic Pharmaceuticals receives USFDA Final Approval for Deferasirox Tablets, 180 mg.", as attached and enclosed with the regulatory filing as submitted by the company to the Indian Bourses, it further read that, Alembic Pharmaceuticals Limited today announced that the Company 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.
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