FDA Alerts
FDA Approves Rectiv For Chronic Anal Fissure Pain
ProStrakan Group plc , a subsidiary of Kyowa Hakko Kirin Co. Ltd. and an international specialty pharmaceutical company, announced that it has received approval from the U.S. Food and Drug Administration (FDA) for Rectiv (nitroglycerin) Ointment 0.4% for the treatment of moderate to severe pain associated with chronic anal fissures.
FDA Alert For Nulojix
Bristol-Myers Squibb (BMS) informed healthcare professionals about the risk evaluation and mitigation strategy ( REMS ) that is required for Nulojix to ensure that the benefits of Nulojix outweigh the risks of post-transplant lymphoproliferative disorder ( PTLD ) and progressive m ultifocal l eukoencephalopathy ( PML ), both of which can be fatal.
FDA Approves Xarelto To Reduce Risk Of Blood Clots
On July 1, the U.S. Food and Drug Administration approved Xarelto ( rivaroxaban ) to reduce the risk of blood clots, deep vein thrombosis ( DVT ), and pulmonary embolism (PE) following knee or hip replacement surgery.
Tylenol Extra Strength Caplets, 225 Count Bottles Recalled
McNeil Consumer Healthcare is recalling one product lot of Tylenol Extra Strength Caplets, 225 count bottles, distributed in the U.S.
Risperdal (risperidone) and Risperidone Recall
Ortho-McNeil-Janssen Pharmaceuticals notified healthcare professionals and the public of a recall of specific lots of Risperdal ( risperidone ) 3mg tablets and risperidone 2mg tablets.
FDA Unveils Final Cigarette Warning Labels
The U.S. Food and Drug Administration (FDA) today unveiled the nine graphic health warnings required to appear on every pack of cigarettes sold in the United States and in every cigarette advertisement.
FDA Examines Ways To Improve Consumer Understanding Of Prescription Drug Ads
Findings from three studies conducted by the US Food and Drug Administration (FDA) confirm that the way information is conveyed and displayed in printed drug advertising affects consumer understanding of prescription medications.
FDA Approves Nulojix For Kidney Transplant Patients
The U.S. Food and Drug Administration today approved Nulojix ( belatacept ) to prevent acute rejection in adult patients who have had a kidney transplant.
FDA: Chantix (varenicline) May Increase Cardiovascular Risk
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.
FDA Sheds Light on Sunscreens
T he Food and Drug Administration (FDA) is taking steps to help protect consumers from skin damage caused by excessive sun exposure.