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FDA Drug Approvals

FDA Approves Gleevec for Rare Gastrointestinal Cancer

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The U.S. Food and Drug Administration granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.

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FDA Approved New Type 2 Diabetes Drug

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Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company today announced the U.S. Food and Drug Administration (FDA) has approved Jentadueto (linagliptin/metformin hydrochloride) tablets, a new tablet combining the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin.  

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Bydureon Approved for Type Two Diabetes

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Some diabetes drugs have to be taken multiple times a day. For many patients, it can be hard to stay on such a strict schedule. Now, patients have the option of a once-weekly drug for type 2 diabetes.

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FDA Approves Advanced Basal Cell Cancer Drug

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Roche announced that Erivedge (vismodegib) capsule was approved by the U.S. Food and Drug Administration (FDA) for adults with a type of skin cancer, called basal cell carcinoma (BCC), that has spread to other parts of the body or that has come back after surgery or that their healthcare provider decides cannot be treated with surgery or radiation.

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FDA Approves Inlyta to Treat Patients With a Type of Advanced Kidney Cancer

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The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.

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Voraxaze Approved To Treat Toxic Methotrexate Levels

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The U.S. Food and Drug Administration approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure.

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Prevnar 13 Approved for New Age Category

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Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company’s pneumococcal conjugate vaccine Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) as a single dose for use in adults. Prevnar 13 is indicated for adults 50 years of age and older for active immunization for the prevention of pneumonia and invasive disease caused by the 13 Streptococcus pneumoniae (S. pneumoniae) serotypes contained in the vaccine.

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Helping Kids Awaiting Heart Transplant

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U.S. Food and Drug Administration officials have given the green light to a device designed to support weakened hearts in children with heart failure who are awaiting a transplant.

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FDA Approves Combo Hypertension Treatment

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U.S. Food and Drug Administration officials have approved new combination hypertension drug Edarbyclor, which combines azilsartan medoxomil and chlorthalidone.

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FDA Approves Insomnia Drug Intermezzo

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The U.S. Food and Drug Administration today approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.

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