More than three dozen drugs and APIs that were originally banned by health regulators in Canada will be allowed into the country because they are medically necessary.
Days after Health Canada said it would talk to the FDA about Apotex, the regulator has banned the import of finished dosage forms and APIs from two of the drugmaker's plants in India.
The three-way spat between Health Canada, local media and Apotex is rumbling on. Late last week Health Canada won an equivocal thumbs-up from the media for its move to quarantine products from one of Apotex's Indian plants, only for the generic drugmaker to hit back with a press release to "set the record straight."
Apotex, the Canadian generics maker that has had years of regulatory run-ins with the FDA, is recalling thousands of bottles of generic Paxil. This time regulators can't point fingers at Apotex. The drugs were manufactured by GlaxoSmithKline and are part of a larger recall for which the FDA spanked GSK.
It's tough luck for Canada's Apotex in its international slug fest with the FDA. An arbitration panel has tossed its claim that the FDA violated the North American Free Trade Act when it banned products from its plants in Toronto and Quebec from 2009 to 2011.
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.