US FDA gives tentative approval to Lupin for Drospirenone tablets

The US Food and Drug Administration (FDA) has given tentative approval to Lupin’s Abbreviated New Drug Application (ANDA), Drospirenone tablets, 4 mg, to market a generic equivalent of Slynd tablets, 4 mg, of Exeltis USA, a statement from Lupin has notified.

Drospirenone tablets had estimated annual sales of $141 million in the US, the statement said.