FDA Revokes Tentative Approval Status for Two Ranbaxy Generics
November 6, 2014 – The FDA revoked the “tentative approval” status for Ranbaxy’s generics to Nexium® (esomperazole – AstraZeneca) and Valcyte® (valganciclovir – Roche). Ranbaxy was waiting for final approval to launch the generics, but this approval has been delayed due to quality issues at its manufacturing plant. FDA said that its original decision granting tentative approvals were in error because of the compliance status of the manufacturing facilities at the time the tentative approvals were granted.
The FDA also removed Ranbaxy’s eligibility for 180 days of generic exclusivity for its generic to Valcyte, allowing the agency to approve generic Valcyte provided by other manufacturers. No company will have generic exclusivity. Currently, Dr. Reddy’s and Endo Pharmaceuticals have received final approval for generics to Valcyte, but generic launches are still pending. The FDA and Ranbaxy have not commented on the generic exclusivity status for Nexium.
As a result of these events, generics to Valcyte are expected to reach the market very soon. Timing of generics to Nexium remains unclear. AstraZeneca projects there will not be any generics to Nexium available in the U.S. this year.
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 regular 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
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