Generic to Testred Available
September 21, 2015 – The U.S. Food and Drug Administration (FDA) approved the first generic to Testred (methyltestosterone) 10mg capsules manufactured by Valeant. Testred was originally approved by the FDA on Dec. 3, 1973. According to IMS Health, sales of methyltestosterone 10mg products were approximately $14.5 million in the U.S. for the 12-month period ending in July 2015.
Methyltestosterone is a synthetic androgen used for primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired) in men, as well as to stimulate puberty in certain males with clearly delayed puberty. It also may be used secondarily in women with advancing inoperable metastatic mammary cancer. Methyltestosterone dosing varies depending on the age, sex, and diagnosis of the individual patient, and is adjusted according to response and appearance of adverse reactions. Methyltestosterone is classified by the Drug Enforcement Agency (DEA) 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.