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Entadfi FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 13, 2021.

FDA Approved: Yes (First approved December 9, 2021)
Brand name: Entadfi
Generic name: finasteride and tadalafil
Dosage form: Capsules
Company: Veru Inc.
Treatment for: Benign Prostatic Hyperplasia

Entadfi (finasteride and tadalafil) is a 5α-reductase inhibitor and phosphodiesterase 5 (PDE5) inhibitor combination indicated for the treatment of urinary tract symptoms caused by benign prostatic hyperplasia (BPH).

  • BPH is an enlargement of the prostate gland which over time can lead to a restriction in the flow of urine. Finasteride and tadalafil are both established treatments for BPH, and tadalafil is also approved for the treatment of erectile dysfunction. Finasteride works by reducing the levels of dihydrotestosterone (DHT) to shrink the enlarged prostate. Tadalafil works by inhibiting PDE5 to relax the smooth muscle in the part of the prostate that surrounds the urethra. 
  • The co-administration of finasteride and tadalafil and has been shown clinically to be more efficacious in treating BPH symptoms than either tadalafil or finasteride alone, with less potential for adverse sexual side effects compared to finasteride monotherapy.
  • Entadfi capsules are administered orally once daily without food at approximately the same time every day for up to 26 weeks.
  • Common adverse reactions associated with finasteride monotherapy include mpotence, decreased libido, decreased volume of ejaculate, breast enlargement, breast tenderness, and rash. Common adverse reactions associated with tadalafil include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb.

Development timeline for Entadfi

Dec 13, 2021Approval FDA Approves Entadfi (finasteride and tadalafil) as a New Treatment for Benign Prostatic Hyperplasia

Further information

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