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AndroGel Manufacturing, Supply Chain & Shortage History

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At a glance

  • Company on AndroGel 1% application / Besins Healthcare, NDA 021015 [7]
  • Controlled substance schedule / Schedule III [1]
  • Product named in TRAVERSE / AndroGel 1.62% [2]
  • FDA class-wide labeling action / February 28, 2025 [3]
  • Further label updates requested / June 2026 [2]
  • Gel strengths / 1% and 1.62% have different dosing [4]

Who holds the AndroGel application?

FDA's Drugs@FDA record for NDA 021015, the AndroGel 1% application, lists Besins Healthcare as the company and shows three marketed prescription forms: 25 mg/2.5 g packets, 50 mg/5 g packets and a 12.5 mg/1.25 g metered gel [7]. FDA's account of the TRAVERSE trial describes it as an FDA-required postmarketing safety trial run by an industry consortium led by manufacturers of AndroGel and Androderm, and names AndroGel 1.62% as the product tested [2].

Is AndroGel a controlled substance?

Testosterone is a Schedule III controlled substance under the Controlled Substances Act, listed at 21 CFR 1308.13(f) [1].

What FDA has changed in testosterone labeling

On February 28, 2025, FDA recommended adding TRAVERSE results to all testosterone product labeling, keeping the Limitation of Use for age-related hypogonadism, and removing boxed-warning language about an increased risk of adverse cardiovascular outcomes, and it required a new blood pressure warning for products that lacked one [3]. FDA said its ambulatory monitoring studies confirmed a blood pressure increase with all testosterone products, class-wide [3]. In June 2026 FDA requested further changes: removing the age-related hypogonadism limitation of use and revising prostate cancer and benign prostatic hyperplasia safety information [2].

Are the testosterone gels interchangeable?

The testosterone gel 1% label says topical testosterone products may have different doses, strengths or application instructions that may result in different systemic exposure, and that dosing for testosterone gel 1% differs from testosterone gel 1.62% [4].

Frequently asked questions

Which company is on AndroGel's FDA application?
FDA's Drugs@FDA record lists Besins Healthcare as the company on the AndroGel 1% application, NDA 021015 [7]. FDA describes the TRAVERSE safety trial as run by an industry consortium led by manufacturers of AndroGel and Androderm [2].
Is testosterone a controlled substance?
Yes. Testosterone is a Schedule III controlled substance under the Controlled Substances Act, listed at 21 CFR 1308.13(f) [1].
What did FDA do to testosterone labels in February 2025?
It recommended adding TRAVERSE results, keeping the age-related hypogonadism limitation of use, and removing boxed-warning language on cardiovascular outcomes. It required a blood pressure warning where one was missing and product-specific blood pressure data where ambulatory monitoring studies were completed [3].
Are testosterone gel 1% and 1.62% the same product?
No. The testosterone gel 1% label states that topical testosterone products may have different doses, strengths or application instructions that may result in different systemic exposure, and that dosing for the 1% gel differs from the 1.62% gel [4].

References

  1. Federal Register :: Request Access. Federal Register :: Request Access
  2. Testosterone Information | FDA. Testosterone Information | FDA
  3. FDA issues class-wide labeling changes for testosterone products | FDA. FDA issues class-wide labeling changes for testosterone products | FDA
  4. U.S. National Library of Medicine, DailyMed. Testosterone gel 1% topical, generic prescribing information. Testosterone gel 1% topical, generic label
  5. Lincoff AM, Bhasin S, Flevaris P, Mitchell LM, Basaria S, Boden WE, et al. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023;389(2):107-117. Cardiovascular Safety of Testosterone-Replacement Therapy
  6. Drug Safety and Availability | FDA. Drug Safety and Availability | FDA
  7. Drugs@FDA: FDA-Approved Drugs, AndroGel NDA 021015. Drugs@FDA: FDA-Approved Drugs
Evidence overview for AndroGel Manufacturing, Supply Chain & Shortage History