New Sustiva Generic Launched
February 1, 2018 – Mylan has announced the launch of its new generic for Bristol-Myers Squibbs’ Sustiva® (efavirenz) 600mg tablets. A non-nucleoside reverse transcriptase inhibitor (NNRTI), Sustiva is indicated to treat HIV-1 infections in patients as young as three months of age when used in conjunction with other antiretroviral drugs.
Recommended dosing with efavirenz for adults is 600mg per day, typically at bedtime and on an empty stomach. Recommended dosing for children is based on weight. Efavirenz is not recommended as a first-line treatment, as side effects can impact the central nervous system and include dizziness, confusion, drowsiness, and insomnia.
Mylan will have 180 days of exclusivity with its efavirenz 600mg tablets. Total 2017 U.S. sales of brand-name Sustiva tablets are estimated at approximately $113 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.