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FDA approves Glenmark and Cipla generics Posted 30/10/2020

Glenmark Pharmaceuticals and Cipla Limited have announced that they have received US food and Drug Administration (FDA) approval to market their generic drug products in the US. Both companies have received approval to market dimethyl fumarate delayed-release (DR) capsules and Glenmark also received approval to market Sirolimus tablets. 

Dimethyl fumarate DR capsules are a generic therapeutic equivalent of Biogen IDEC Inc’s Tecfidera. Both Glenmark and Cipla have the go ahead to market 120 mg and 240 mg formulations for the treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Sirolimus tablets are a generic version of PF Prism CV's rapamune tablets. They are prescribed to prevent rejection of kidney transplants either alone or in combination with other medications. The drug is a mammalian target of rapamycin (mTOR) inhibitor immunosuppressant and is not recommended for patients with lung or liver transplants. Glenmark will now be able to market 0.5 mg, 1 mg and 2 mg versions of the tablets.

Glenmark reported that, according to IQVIA sales data for the 12-month period ending August 2020, the market for Sirolimus achieved annual sales in the region of US$119.7 million and that of Tecfidera DR capsules reached US$3.8 billion. They also noted that their current portfolio consists of 165 products authorized for US distribution and they have 45 abbreviated new drug applications (ANDAs) pending approval.

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