Warning Letters 2011

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FDA Drug Safety Communication: Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors

      Safety Announcement  Additional Information for Patients and Consumers  Additional Information for Healthcare Professionals  Data Summary  Table of epidemiological studies evaluating fracture risk with proton pump inhibitors     Safety Announcement  [05-25-2010] The U.S. Food and Drug Administration (FDA) is revising the prescription and over-the-counter (OTC) labels for a class of drugs called proton pump…

Clinical Investigator Inspection List (CLIIL)

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Pediatric Exclusivity Granted

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FDA Drug Safety Communication: Special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate mesylate) capsules

  Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [03-29-2011] The U.S. Food and Drug Administration (FDA) is alerting the public to important storage and handling requirements for Pradaxa (dabigatran etexilate mesylate) capsules. Due to the potential for product breakdown from moisture and loss of potency, Pradaxa capsules should only…

Current Drug Shortages

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Single-Ingredient Oral Colchicine Video

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Long-Acting Beta-Agonists (LABAs) Video

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