Generic Launched for Lexiva
September 18, 2017 – Mylan has launched its generic to ViiV Healthcare’s Lexiva® (fosamprenavir) 700mg tablets, a protease inhibitor indicated to treat HIV-1 when used in combination with other antiretroviral agents. The recommended dosing varies based on treatment history, as well as whether the patient has been diagnosed with hepatic impairment. Dosing for pediatric patients is based on weight. Fosamprenavir tablets can be taken with or without food in both adult and pediatric patients.
Estimated 2016 sales of Lexiva, both tablets and oral suspension, totaled $39 million.
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 U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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 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.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.