Latest Headlines

Latest Headlines

Apotex recalls Paxil tainted at GSK plant

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.

NAFTA says FDA was in its rights to ban Apotex plants

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.

FDA's ban on Apotex India plant stems from faked test data

In April, the FDA banned a plant in Bangalore, India, owned by Canadian generics maker Apotex. An FDA warning letter posted today explains why.

FDA says Apotex India plant has faked data for years

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.

Canadian drugmaker's Indian plant joins FDA import ban parade

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.

Apotex plant in India tagged with import ban

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.

Apotex ordered to pay AstraZeneca half its generic Prilosec profits

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.

Apotex sued over problems on contraceptive packaging line

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.

More recalls as Hospira struggles to right manufacturing

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.

Drugmakers 'illegally' withhold samples from would-be copycats

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.