Generic to Kaletra Oral Solution Approved
January 3, 2017 - The U.S. Food and Drug Administration (FDA) approved the Lannett Company’s AB-rated generic to AbbVie’s Kaletra® (lopinavir/ritonavir oral solution), 80mg/20mg per mL. Kaletra is an HIV-1 protease inhibitor indicated for use in combination with other antiretrovirals for the treatment of HIV-1 infection in adults and children (14 days and older). Lannett plans on launching its generic lopinavir/ritonavir oral solution in the near future. Generics to AbbVie’s Kaletra capsules and tablets have not yet been approved.
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
- 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 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.