First Generic Launched for Reyataz
December 27, 2017 – Teva Pharmaceuticals has announced the launch of its generic for Bristol-Myers Squibb’s Reyataz® (atazanavir sulfate) capsules. Atazanavir sulfate is approved by the U.S. FDA to treat HIV-1 infection, when used in combination with other antiretroviral agents, in patients six years of age and up who weigh a minimum of 15kg (33 lbs).
A protease inhibitor, atazanavir sulfate works by interfering with HIV’s ability to replicate inside the body. It is the fifth generic drug that Teva has brought to market in the U.S. to treat HIV-1. Recommended dosing is based on a number of factors, including the patient’s age, weight, and treatment history.
IQVIA (formerly QuintilesIMS) reported that sales of brand name Reyataz® had totaled $402 million in the U.S. as of October 2017.
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.