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Finasteride Manufacturing, Supply & Shortage History

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At a glance

  • Brand 5 mg / Proscar, NDA 020180, approved 06/19/1992 [1]
  • Brand 1 mg / Propecia, NDA 020788, approved 12/19/1997 [2]
  • Current application holder / Organon, for both brand products [2][1]
  • Listed dosage form / Oral tablets, 1 mg and 5 mg [2][1]
  • Manufacturing supplements on record / Propecia CMC-Control 10/30/2002 and CMC 01/11/2016; Proscar CMC 07/06/2015 [2][1]
  • Latest Propecia labeling supplement / S-030, approved 08/01/2022 [2]
  • Current Propecia label / Effective 2024-10-14 [3]
  • Latest Proscar labeling supplement / S-050, approved 03/18/2026 [1]

Who holds the finasteride applications today

Proscar, the 5 mg tablet for benign prostatic hyperplasia, was approved on 06/19/1992 as a new molecular entity under priority review [1]. Propecia, the 1 mg tablet for male pattern hair loss, was approved on 12/19/1997 as a new dosage form [2]. Organon holds both new drug applications today, and both products are listed as prescription drugs in those records [2][1].

Generic finasteride tablets are also FDA-approved in both the 1 mg and 5 mg strengths under abbreviated new drug applications [3].

HealthRX.com offers finasteride 1 mg by prescription.

How the manufacturing record is filed

A Drug Master File is a submission used to give the FDA confidential detail about the facilities, processes or materials used in manufacturing, processing, packaging or storing a drug product [4]. DMFs are not required by statute or regulation and are neither approved nor disapproved; the agency reviews their technical contents when an application references them [4]. One function of the file is to let a party reference the material without the DMF contents being disclosed to that party [4].

Manufacturing changes to an approved product appear as supplements on the application. Propecia's history includes a Manufacturing (CMC)-Control supplement dated 10/30/2002 and a Manufacturing (CMC) supplement dated 01/11/2016 [2]. Proscar's includes a Manufacturing (CMC) supplement approved 07/06/2015 [1]. These entries record that chemistry, manufacturing and controls supplements were filed against each application.

What the records show about the product form

The FDA records for Proscar and Propecia list both brands as oral tablets, finasteride 1 mg and 5 mg [2][1]. Propecia tablets are coated, and the coating prevents contact with the active ingredient during normal handling as long as the tablet has not been broken or crushed [3].

Frequently asked questions

Who holds the Proscar and Propecia applications now?
Organon holds both new drug applications: NDA 020180 for Proscar 5 mg, first approved 06/19/1992, and NDA 020788 for Propecia 1 mg, first approved 12/19/1997 [2][1].
When was the current Propecia label issued?
The most recent Propecia labeling supplement on the approval record, S-030, was approved 08/01/2022, and the label now in effect is dated 2024-10-14 [2][3].
Are generic finasteride tablets FDA-approved?
Yes. Generic finasteride tablets are approved in both the 1 mg and 5 mg strengths under abbreviated new drug applications [3].
Do the FDA records list a topical or injectable finasteride?
No. The FDA records for Proscar and Propecia list oral tablets only [2][1], and there is no FDA-approved topical or injectable finasteride [3].
What manufacturing changes appear on the finasteride applications?
Propecia has a Manufacturing (CMC)-Control supplement dated 10/30/2002 and a Manufacturing (CMC) supplement dated 01/11/2016; Proscar has a Manufacturing (CMC) supplement approved 07/06/2015 [2][1].
Are the two brand products prescription drugs?
Yes. Both Propecia and Proscar are listed as prescription products in the FDA application records for NDA 020788 and NDA 020180 [2][1].

References

  1. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  2. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  3. U.S. National Library of Medicine, DailyMed. Propecia (finasteride 1 mg) tablets, Organon prescribing information. Propecia (finasteride 1 mg) tablets, Organon label
  4. Drug Master Files (DMFs) | FDA. Drug Master Files (DMFs) | FDA
Evidence overview for finasteride: Finasteride Manufacturing, Supply & Shortage History