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FDA Bans Import of Ranbaxy Generics

by Elizabeth Davis on January 24, 2014 at 3:00 pm

The FDA has prohibited generic drug maker Ranbaxy from making and selling pharmaceutical products for the US market from its facility in Toansa, India, “to prevent substandard quality products from reaching US consumers,” according to the director of the FDA’s Office of Compliance. The decision was made after an inspection of the facility in question in January 2014. Three of Ranbaxy’s other facilities were also barred from making products to be imported to the US in 2012.

How might this affect you? First, Ranbaxy has been planning to launch generic versions of blood pressure med Diovan and proton pump inhibitor Nexium in the US, and this will almost definitely delay those releases.

Other generic drugs currently made by the company may also be unavailable—the most recent ban means that most of Ranbaxy’s products are affected. If a generic isn’t available from another manufacturer, this will mean at least temporary shortages. Ranbaxy makes generics for many drugs in the US, including several antibiotics, Ambien (zolpidem), Imitrex (sumatriptan), Lipitor, (atorvastatin), Neurontin (gabapentin), Zocor (simvastatin), and Zestril and Prinivil (lisinopril), among others, though in most cases they are not the only generic supplier.

If you’re currently taking a generic drug manufactured by Ranbaxy, the FDA recommends continuing to take your medication as prescribed and discussing any concerns with your doctor or pharmacist before making any changes.

For more information, see the FDA news release here.


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