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Weekly Drug News Round Up - April 29, 2015

FDA Approves Lilly’s Cyramza for Adjunct Treatment of Metastatic Colorectal Cancer

The labeling for Cyramza contains Boxed Warnings for hemorrhage, GI perforation, and impaired wound healing Read More...

Cyramza (ramucirumab) has been approved by the U.S. Food and Drug Administration (FDA) in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. Cyramza is also approved for the treatment of gastric and non-small cell lung cancers. Cyramza is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist. In clinical trials, patients treated with the Cyramza-FOLFIRI combination achieved a median overall survival of 13.3 months and a reduced risk of death by 15 percent.

FDA Approves First-Time Generic for BMS’s Abilify

FDA-approved generic drugs meet the same rigorous standards as the reference brand-name product Read More...

Abilify (aripiprazole) is a blockbuster atypical antipsychotic drug used to treat the mental illnesses schizophrenia and bipolar disorder. On April 28, the U.S. Food and Drug Administration (FDA) okayed the first generic versions of Abilify, which will save millions of dollars for patients and healthcare systems. Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals have received the FDA approval to market the generic drug. Aripiprazole contains a Boxed Warning of increased risk of death when used off-label in the treatment of elderly for dementia-related psychosis. Common side effects include nausea, vomiting, constipation, headache, and dizziness.

Kybella Approved for Double Chin

Common side effects after injection include swelling, bruising, pain, numbness, redness and localized hard tissue Read More...

Kybella (deoxycholic acid) has been approved by the U.S. Food and Drug Administration to treat excess fat below the chin, a condition best known as "double chin." Deoxycholic acid is a naturally occurring molecule in the body that aids in the breakdown of dietary fat. Kybella is injected into fat tissue in the "submental" area below the chin. However, the agency warned Kybella can cause serious side effects, including nerve injury, uneven smile, facial muscle weakness and trouble swallowing. Kybella shouldn't be used outside the chin area, or near an infection on the chin area. Kybella is produced by Kythera Biopharmaceuticals.

New Drug Class Slashes 'Bad' Cholesterol, Review Finds

PCSK9 inhibitors are monoclonal antibodies (MABs), a type of biologic drug Read More...

By now you've heard of statins, also known as HMG-CoA reductase inhibitors. Available since the late 1980's, statins include well-known blockbusters like atorvastatin (Lipitor) and rosuvastatin (Crestor). As published this week in the in Annals of Internal Medicine, a new investigational class of drugs for lowering LDL cholesterol is under study. The new agents inactivate PCSK9 via inhibition, boosting the number of receptors available to capture LDL for metabolism. PCSK9 inhibitors will target patients who cannot tolerate or have poor effect with statins, and might be combined with statins, too, as research progresses.

Wider Use of Naloxone Could Cut Opioid Overdoses

Prescription opioids caused more than 16,000 deaths in the United States in 2013 Read More...

Naloxone (Evzio, Narcan) is an easy-to-administer prescription drug that can be lifesaving if given in time to people who have overdosed on prescription opioids or heroin. Health officials are now recommending to expand the groups of emergency medical service (EMS) workers that can administer naloxone. CDC research published in the American Journal of Public Health found that advanced EMS staffers were more likely than basic EMS staffers to administer naloxone. Only 12 states allowed basic EMS staffers to administer naloxone for a suspected opioid overdose, but all 50 states allowed advanced EMS staffers to do so, per the CDC.

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