Friday, 21 February 2020

Glenmark receives ANDA approval for Deferasirox Tablets

07 January 2020 | News

It is the generic version of Exjade® Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg, of Novartis Pharmaceuticals Corporation

Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Deferasirox Tablets for Oral  Suspension,  125  mg,  250  mg  and  500  mg,  the  generic  version  of  Exjade® Tablets  for  Oral Suspension, 125 mg, 250 mg and 500 mg, of Novartis Pharmaceuticals Corporation.  

According to IQVIATM sales data for the 12‐month period ending November 2019, the Exjade® Tablets  for Oral  Suspension,  125 mg,  250 mg  and  500 mg market2 achieved annual  sales  of approximately $106.4 million.

Glenmark’s  current  portfolio  consists  of  165  products  authorized  for  distribution  in  the  U.S.  marketplace and 43 ANDA’s pending approval with the U.S. FDA.

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