The FDA has approved Veru Inc's (NASDAQ:VERU) Entadfi to treat urinary tract symptoms caused by an enlarged prostate called benign prostatic hyperplasia (BPH).

  • Entadfi (finasteride and tadalafil) capsule has shown to be more effective in treating urinary tract symptoms caused by BPH with less potential for adverse sexual side effects than finasteride monotherapy. 
  • Entadfi dosing is one capsule orally once a day. The FDA-approved indication is to initiate treatment of the signs and symptoms of benign prostatic hyperplasia in men with an enlarged prostate for up to 26 weeks.
  • The drug will be marketed and distributed by Veru's own direct-to-patient telemedicine and telepharmacy services platform. 
  • Veru has also partnered with GoodRx Holdings Inc (NASDAQ:GDRX), a US-based digital resource for healthcare, to reach its almost 20 million monthly visitors.
  • Also, see Benzinga's Full FDA Calendar here.
  • Price Action: VERU shares 8.16% at $6.76 during the market session on the last check Monday.