Drug News

Stay up-to-date on the latest drug news. Learn about new drug approvals, labeling changes, expanded indications, recalls, and approvals of generic formulations. These drug news updates are compiled from the latest information from Facts & Comparisons® and the U.S. Food and Drug Administration.

(Updated May 22, 2017)

The FDA has approved the following drug:‚Äč
  • Dexlansoprazole 60 mg delayed-release oral capsules, the generic version of Dexilant, to heal all grades of erosive esophagitis; to maintain healed erosive esophagitis and relieve heartburn; and to treat symptomatic nonerosive gastroesophageal reflux disease.
 
The FDA has approved the following expanded indications:
  • Kalydeco (ivacaftor) oral tablets and oral granules for the treatment of cystic fibrosis in patients age 2 years and older who have one mutation in the cystic gene that is responsive to ivacaftor. The drug can now treat 33 mutations.
  • Keytruda (pembrolizumab) intravenous injection for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy; and for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Keytruda is also indicated for treatment of unresectable or metastatic melanoma; metastatic non–small cell lung cancer (NSCLC); recurrent or metastatic head and neck squamous cell carcinoma; refractory classical Hodgkin lymphoma; and in combination with pemetrexed plus carboplatin as first-line treatment for patients with metastatic nonsquamous NSCLC. 
 
The FDA has issued the following safety alert:
  • Canagliflozin (InvokanaInvokametInvokamet XR) use in patients treated for diabetes causes an increased risk of leg and foot amputations. Patients should not stop or change their diabetes treatment without speaking with their health care provider, and they should immediately alert their health care provider if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet. Health care providers should follow the recommendations in the canagliflozin drug labeling and monitor patients for the signs and symptoms described. For more information regarding this safety alert click here

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