Safety AnnouncementAdditional Information for Patients Additional Information for Healthcare Professionals Data Summary References   Safety Announcement [6-30-2011] Normal 0 false false false MicrosoftInternetExplorer4 /* Style Definitions */ table.MsoNormalTable {mso-style-name:”Table Normal”; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-parent:””; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:”Times New Roman”; mso-ansi-language: mso-fareast-language: mso-bidi-language:} The U.S. Food and Drug Administration…
Breakdown of FDAAA Completed Pediatric Studies
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FDA Drug Safety Communication: Modified dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney disease
 Safety AnnouncementAdditional Information for Patients with CKDAdditional Information for Healthcare Professionals who treat Patients with CKDTable of Key TrialsReferences  Safety Announcement [6-24-2011] Normal 0 false false false MicrosoftInternetExplorer4 /* Style Definitions */ table.MsoNormalTable {mso-style-name:”Table Normal”; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-parent:””; mso-padding-alt:0pt 5.4pt 0pt 5.4pt; mso-para-margin:0pt; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:”Times New Roman”; mso-ansi-language: mso-fareast-language: mso-bidi-language:}…
Orange Book Current Cumulative Supplement
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FDA Drug Safety Communication: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease
 Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary  Safety Announcement [6-16-2011] The U.S. Food and Drug Administration (FDA) is notifying the public that the smoking cessation aid Chantix (varenicline) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information…
FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer
Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary References  Safety Announcement [6-15-2011] The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be…
Questions and Answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S.
On June 14, 2011 the U.S. Food and Drug Administration (FDA) announced new requirements for sunscreens currently sold over-the-counter (OTC) (i.e. non-prescription). These requirements support the Agency’s ongoing efforts to ensure that sunscreens meet modern-day standards for safety and effectiveness. The new requirements, as well as several proposed changes for future rules, are outlined in…
Sunscreen
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Drugs to be Discontinued
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