It turns out that Canadian drugmaker Apotex's manufacturing problems do not all stem from entanglements in the U.S. The generic drugmaker, which last year complained to a NAFTA court that the FDA had been picking on it, is now recalling packages of contraceptive pills in Canada because they may contain too few active tablets.
On Monday, Health Canada upgraded the recall alert for Alysena 28 birth control pills to a Type I after some packages were found to have 14 active contraceptive pills and 14 placebos, instead of the 21 active and 7 placebos that they should contain. The regulators initially tagged the voluntary recall by Apotex a Type II when it was posted last week. What prompted the agency to bump up the urgency was not explained. Last year Health Canada announced that Apotex was recalling one lot of its hypertension med, Apo-Ramipril 5-mg capsules, because some were found to be empty of any ingredients.
Apotex has encountered troubles with the FDA for a number of years. Just last month, the agency issued a warning letter to two Apotex plants in Canada, noting that some of the problems had come up in previous inspections. In 2011, the FDA lifted an import ban against Apotex that had been in place for about two years for problems outlined in warning letters issued in 2009 and 2010.
Once the ban was lifted, Apotex complained to the International Centre For Settlement of Investment Disputes that the FDA action "decimated" its business and cost it $520 million in lost sales. It argued that the ban violated NAFTA, claiming the FDA treated Apotex less fairly than other companies, like Teva Pharmaceutical ($TEVA). Apotex is asking the treaty oversight agency for arbitration in an effort to get the U.S. to reimburse it.
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