Sustiva Generic Launched
January 2, 2018 – Rising Pharmaceuticals, a subsidiary of Aceto, has launched its generic for Bristol-Meyers Squibb’s Sustiva® (efavirenz) 50mg and 200mg capsules. Efavirenz is approved to treat HIV-1, when used in combination with other antiretroviral agents, in adults and pediatric patients as young as three months of age who weigh no less than 3.5kg (7.7 lbs).
A non-nucleoside reverse transcriptase inhibitor, efavirenz works by interfering with HIV’s ability to replicate itself in the body. Recommended dosing for adults is 600mg taken at bedtime on an empty stomach. For children, recommended dosing is based on weight.
Total U.S. sales of brand name Sustiva capsules in the twelve months ending on October 31, 2017, reached approximately $4.21 million, according to IQVIA (formerly QuintilesIMS).
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.