In April, the FDA banned a plant in Bangalore, India, owned by Canadian generics maker Apotex. An FDA warning letter posted today explains why.
In April, the FDA banned a plant in Bangalore, India, owned by Canadian generic drugmaker Apotex. A warning letter sent last week and posted today by the FDA says that among other issues, it found that the company had deleted data of failed test results and then reported that the batches had passed.
The FDA has banned a handful of plants from some of India's biggest drugmakers in the last year, actions that have led to grumbling that the regulator is picking on Indian-owned operations. But now a plant in India owned by a Canadian firm has gotten the same treatment, an import alert that blocks products from being shipped to the U.S.
The FDA has again issued an import alert against a plant owned by Canadian generic drugmaker Apotex, this one in India. The last time the agency took that kind of action, Apotex took the matter to international authorities in a North American Free Trade Agreement complaint.
An award of $76 million may not sound like much in the big-dollar world of pharma, but for a branded drug company, it always feels good to win one against a generic drugmaker that has jumped the gun with a generic. That is how much a court says AstraZeneca should be paid by Apotex.
Forty-five women are seeking $800 million (U.S. $778.8 million) in a class-action lawsuit filed Friday, claiming a packaging foul-up by Apotex led them to take placebos instead of the active birth control pills.
It has been a particularly bad few days for Hospira, with both the company and the FDA alerting healthcare providers of problems with multiple lots of its drugs. That was in addition to an alert for one of its medical products.
Risk-management plans may be a burden for new drug launches, but they're proving to be a weapon against generic competition, too. As the New York Times reports, generics makers can't buy the supplies they need to knock off a product, thanks to REMS restrictions. So, they have to resort to asking branded drugmakers for supplies--and some of those companies aren't cooperating.
The generic drug manufacturer, which for nearly two years had its products banned from the U.S., has received a warning letter for two of its in Canada plants, one in Ontario and one in Toronto that has received a warning letter before.
Even as the clock is ticking down on the patent for its super blockbuster Singulair, Merck ($MRK) got smacked Friday with a negative decision in its battle with genericmaker Apotex over Merck's blockbuster Nasonex spray.