First Generic to Valeant
September 21, 2015 – The U.S. Food and Drug Administration (FDA) granted approval to the first generic to Valeant’s Testred (methyltestosterone) 10mg capsule. Methyltestosterone as a synthetic androgen used for primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired) in men. Methyltestosterone is also indicated to stimulate puberty in carefully selected males with clearly delayed puberty, and secondarily in women with advancing inoperable metastatic mammary cancer. Testred was originally approved by the FDA on December 3, 1973. Dosing for Methyltestosterone varies depending on age, sex, and diagnosis of individual patient; and could be adjusted according to the patient’s response and appearance of adverse reactions. According to the Drug Enforcement Agency (DEA), Methyltestosterone is classified as a Schedule III drug.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.