VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT - In a regulatory filing submitted to the Indian Stock Exchanges, Vaoddara headquartered pharmaceutical products manufacturing company Alembic Pharmaceuticals Ltd said of having got nod to market medicine to treat iron levels in blood, especially to treat chronic iron overload due to blood transfusions in patients of 2 years of age and older.
In a company press-release as submitted to the Indian Bourses, it read that the Company has received US Food & Drug Administration (USFDA) Approval for its following Abbreviated New Drug Applications (ANDAs) :-
1. Final Approval for Deferasirox Tablets 90 mg and 360 mg.
2. Final Approval for Deferasirox Tablets for Oral Suspension, 125 mg, 250 mg, and 500 mg.
3. Tentative Approval for Deferasirox Tablets 180 mg.
2. Final Approval for Deferasirox Tablets for Oral Suspension, 125 mg, 250 mg, and 500 mg.
3. Tentative Approval for Deferasirox Tablets 180 mg.
Above narrated medicines are used to treat, iron levels in blood, especially to treat chronic iron overload due to blood transfusions in pateients of 2 years of age and older.
Deferasirox Tablets 90 mg and 360 mg is equivalent to Jadenu Tablets, 90 mg and 360 mg, of Novartis Pharmaceuticals Corporation (Novartis) and according to IQVIA estimated market size of the medicine stands at US $ 415 million for twelve months ended on December 2018.
Whereas Deferasirox Tablets for Oral Suspension, 125 mg, 250 mg, and 500 mg, is equivalent to Exjade Tablets for Oral Suspension, 125 mg, 250 mg, and 500 mg, of Novartis Pharmaceuticals Corporation (Novartis) and according to IQVIA estimated market size of the medicine stands at US $ 135 million or twelve months ended on December 2018.
The company has got a tentative approval for Deferasirox Tablets 180 mg, which is equivalent to Jadenu Tablets, 180 mg of Novartis Pharmacueticals Corporation (Novartis) and according to IQVIA estimated market size of the medicine stands at US $ 59 million for twelve months ended on December 2018.
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