Lupin receives USFDA tentative approval for Tadalafil Tablets

Lupin announced that it has received tentative approval for its Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg from the United States Food and Drug Administration (FDA) to market a generic version of Eli Lilly and Company's Galls Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg.

Lupin's Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg is the generic version of Eli Lilly and Company's Cialis Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg. It is indicated for the treatment of: erectile dysfunction, the signs and symptoms of benign prostatic hyperplasia erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia.

Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg had annual sales of approximately USD 1949.2 million in the US (IQVIA MAT April 2018).

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