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Lupin Receives Tentative FDA Approval for Generic Tadalafil Tablets

Pharma major 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 Cialis 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). – Medical Buyer Bureau

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