Natco Pharma gets USFDA nod to market renal disease drug
New Delhi: Natco Pharma on Monday said it has received approval from the US health regulator to market Lanthanum Carbonate chewable tablets used in treatment of patients with end stage renal disease.
The company has received final approval from the US Food and Drug Administration (USFDA) to market Lanthanum Carbonate chewable tablets in various strengths, Natco Pharma said in a regulatory filing.
"The product, as the first generic, will be launched shortly in the USA market," it added.
Natco's Lanthanum Carbonate strengths are generic equivalent of Shire Development LLC's Fosrenol chewable tablets and are indicated to reduce serum phosphate in patients with end stage renal disease (ESRD).
As per IMS MAT sales data, Fosrenol tablets had sales of USD 122.4 million during June 2017 in the US market.
Natco and Lupin had entered into an agreement on September 1, 2008 to jointly commercialise generic equivalents of Fosrenol chewable tablets.
The company has received final approval from the US Food and Drug Administration (USFDA) to market Lanthanum Carbonate chewable tablets in various strengths, Natco Pharma said in a regulatory filing.
"The product, as the first generic, will be launched shortly in the USA market," it added.
Natco's Lanthanum Carbonate strengths are generic equivalent of Shire Development LLC's Fosrenol chewable tablets and are indicated to reduce serum phosphate in patients with end stage renal disease (ESRD).
As per IMS MAT sales data, Fosrenol tablets had sales of USD 122.4 million during June 2017 in the US market.
Natco and Lupin had entered into an agreement on September 1, 2008 to jointly commercialise generic equivalents of Fosrenol chewable tablets.
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