Finasteride Regulatory Status: US, EU, Canada, UK Approval History and Current Standing

Two US approvals, two indications

The FDA approved finasteride 5 mg as Proscar (NDA 020180) on June 19, 1992, as a new molecular entity under priority review; the 1 mg tablet, Propecia (NDA 020788), was approved on December 19, 1997, as a new dosage form [1][2]. Organon holds both applications [1][2].

Proscar is indicated for symptomatic BPH in men with an enlarged prostate — to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of surgery including TURP and prostatectomy — and with doxazosin to reduce the risk of symptomatic progression; it is not approved for prevention of prostate cancer [3]. Propecia is indicated for male pattern hair loss in men only, and efficacy in bitemporal recession has not been established [5].

Forms, generics and label limits

Generic 1 mg and 5 mg tablets are FDA-approved under many ANDAs and carry the same labeled risks as the brand [5]. Drugs@FDA lists only oral tablets; no topical or injectable finasteride is FDA-approved, and both strengths are prescription-only [5]. Propecia is not indicated for women or children; pregnancy is a contraindication, and women who are or may be pregnant should not handle crushed or broken tablets because of the risk of abnormal external genitalia in a male fetus [5]. For the FDA-approved hair-loss tablet, see finasteride 1 mg [1].

Safety entries on the current labels

FDA application histories record labeling supplements approved on June 9, 2011 for both products [1][2]. The current Proscar label reports Gleason 8 to 10 prostate cancer in 1.8% of men taking finasteride 5 mg versus 1.1% on placebo in the 7-year Prostate Cancer Prevention Trial, and states that 5-alpha reductase inhibitors may increase the risk of high-grade prostate cancer [3].

On May 31, 2022 the FDA sent a safety labeling change order under section 505(o)(4) of the FD&C Act citing new safety information on suicidal ideation and behavior, additional risk of sexual dysfunction and psychoneurocognitive events; supplement S-030, approved August 1, 2022, changed the wording to 'depression, suicidal ideation and behavior' [6]. That wording appears in Propecia's postmarketing section; the current Proscar postmarketing section lists depression and suicidal ideation [6][3]. Neither product has a boxed warning [5][3]. Propecia also lists sexual dysfunction that continued after discontinuation — erectile dysfunction, libido, ejaculation and orgasm disorders — and male infertility or poor seminal quality [5].

UK and Sweden: leaflet update

The UK Medicines and Healthcare Products Regulatory Agency and the Swedish Medical Products Agency both updated their Propecia patient information leaflets to say that persistence of erectile dysfunction after discontinuation of treatment has been reported in post-marketing use [4].