Lupine Receives USFDA Presumptive Approval for ANDA Drospirenone Tablets | Tech Reddy

Lupine today announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Drospirenone Tablets, 4 mg, to market the generic equivalent of Exeltis, Slind Tablets, 4 mg. USA Inc.

Drospirenone tablets (RLD Slynd) had annual sales of $141 million in the US.

S. (IQVIA MAT September 2022).

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