Hypertension drug from India no longer banned in EU—but 100s of others still are
- In Jaunary, the European Medicines Agency (EMA) suspended close to 50 generic drugs, including drugs for diabetes, depression, hypertension, and other medical conditions, due to flawed clinical studies conducted at a CRO in Hyperabad, India.
- Although the list included 48 drugs, because there are numerous versions of many of the drugs, the total list includes almost 700 drugs.
- However, the EMA has recommended that nebivolol, used to treat hypertension, be restored to good standing. Amerigen Pharmaceutical received an FDA approval for a generic version of nebivolol last month.
The original complaint about the "flawed" trials in Hyderabad came after French regulators inspected the GVK Biosciences facility last year and found numerous irregularities related to manipulated data from electrocardiograms. These flaws cast doubt on the integrity of the overall trial methodology at the facility.
The difference for nebivolol is that the FDA inspected the facility in Hyderabad roughly four months later and said it did not find any irregularities and would therefore move forward with the approval of Amergien Pharmaceutical's nebivolol—which provided the impetus for drug manufacturers to request that nebivolol be removed from the list of suspended drugs.