Veru jumped over 13% in premarket trading it announced FDA approval of ENTADFI.The company today announced that the U.S. Food and Drug Administration (FDA) has approved ENTADFITM for the treatment of urinary tract symptoms caused by an enlarged prostate called benign prostatic hyperplasia (BPH).
ENTADFI (finasteride and tadalafil) capsule for oral use has also been shown to be more effective to treat urinary tract symptoms caused by BPH with less potential for adverse sexual side effects compared to finasteride monotherapy. ENTADFI dosing is one capsule orally once a day, and 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.
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