The discontinuation is not related to the safety or efficacy of the drug but due to the the multiple manufacturers that currently provide supply to the U.S. market. The affected products are:
- Axiron 30mg/1.5mL (NDC 0002-1975-90)
- Axiron 30mg/1.5mL (NDC 0002-1975-61)
- Generic Testosterone 30mg/1.5mL (NDC 66993-963-89)
Axiron solution is an androgen indicated for testosterone replacement therapy in adult males with congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism. It is supplied as a 90mL pump containing 60 metered pump or twist actuations with an applicator.
For more information call (800) 545-5979 or visit FDA.gov.