Cialis ® (tadalafil) tablets

2.5 mg, 5 mg, 10mg, 20 mg tablets

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

CIALIS® (tadalafil): Approval and Indication

Cialis has been approved for the treatment of ED, signs and symptoms of BPH, and both ED and signs and symptoms of BPH together.

US_cFAQ_TAD252_APPROVAL_INDICATION
US_cFAQ_TAD252_APPROVAL_INDICATION
en-US

Detailed Information

The FDA reviews and approves new prescription drugs in the United States.1

The FDA has approved tadalafil for 4 different uses1:

  • use as needed for the treatment of ED in November 2003
  • use once daily for the treatment of ED in January 2008
  • use once daily for the treatment of signs and symptoms of BPH in October 2011, and
  • use once daily for the treatment of both ED and BPH together in October 2011.1

Reference

1Cialis [package insert]. Indianapolis, IN: Eli Lilly and Company; 2018.

Glossary

BPH = benign prostatic hyperplasia

ED = erectile dysfunction

FDA = Food and Drug Administration

Date of Last Review: February 17, 2021


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