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01/19/2022

Lupin obtains FDA approval, tentative OK for 2 generics

The Food and Drug Administration approved Lupin’s sevelamer carbonate for oral suspension and gave tentative approval for azilsartan medoxomil tablets.
Sandra Levy
Senior Editor
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Lupin has received the Food and Drug Administration’s approval for a new generic, and tentative approval for a second product.

The FDA gave its blessing to Lupin for sevelamer carbonate for oral suspension, 0.8 g and 2.4 g packets.

The product is the generic of Genzyme’s Renvela.

[Read more: FDA approves 3 Lupin generics]

It will be manufactured at Lupin’s Goa facility in India.

Sevelamer carbonate for oral suspension had a market value of $51.7 million, according to September 2021 IQVIA data.

Lupin also received tentative approval for azilsartan medoxomil tablets, in dosage strengths of 40 mg, and 80 mg.

The medication is the generic of Arbor’s Edarbi tablets.

[Read more: Lupin intros authorized generic Duexis]

This product will be manufactured at Lupin’s Nagpur facility in India.

Azilsartan medoxomil tablets had a market value of $103.4 million, according to IQVIA September 2021 data.

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