- US District Judge Beryl Howell said last week that the FDA can revoke approval of Ranbaxy's generic Nexium (esomeprazole) and Valcyte (valganciclovir), but the judge wants to know why it took so long.
- The FDA began an investigation of Ranbaxy's manufacturing facilities in 2006, but did not revisit any of the ANDAs given tentative approval in in 2007 and 2008 (including esomperazole and valganciclovir). Ranbaxy sued the FDA in November 2014 after the agency revoked approval of generic Nexium and Valcyte.
- Although the judge chastised the FDA for taking so long to revoke the approvals, the judge recognized that Ranbaxy had log-jammed the process at every step along the way, thus contributing to the delayed response.
The case was by no means straightforward. In a 71-page document, Judge Howell laid out her views on the case and the deliberations that ultimately led to the FDA winning the case. In fact, after the FDA revoked the two ANDAs from Ranbaxy, it subsequently gave approvals for the two drugs to three other companies, including Endo, Dr. Reddy's and Teva.
Ranbaxy felt that it was unfair for the FDA to revoke the approvals six years after they were granted. The FDA said it attempted to move the investigation of cGMP violations at Ranbaxy's manufacturing facilities ahead, but Ranbaxy was not responsive for long periods of time. At one point, it took the India-based biopharma one year to respond to audit reports. Finally, the FDA fined Ranbaxy $500 million after a fully fledged criminal investigation.