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Weekly Drug News Round Up - July 30, 2014

GSK’s Flonase Allergy Relief Approved for OTC Use

In 2010, Americans lost more than 6 million work and school days due to allergic rhinitis Read More...

Roughly 50 million people in the U.S. suffer from nasal allergies. The U.S. Food and Drug Administration (FDA) has approved Flonase Allergy Relief (fluticasone propionate 50 mcg spray) as an over-the-counter (OTC) nasal spray for the symptoms of hay fever or upper respiratory allergies. Flonase Allergy Relief can be used for nasal and eye-related allergy symptoms, including runny and itchy nose, sneezing, congestion, and itchy and watery eyes. Flonase Allergy Relief will be available OTC at full prescription strength starting in early 2015.

Targiniq ER Approved as an Abuse-Deterrent Painkiller

Targiniq ER has properties that are expected to deter, but not totally prevent, abuse by snorting and injection Read More...

In an effort to combat the rampant misuse and abuse of narcotic prescription drugs, the U.S. Food and Drug Administration (FDA) has approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an opioid analgesic used to treat chronic, severe pain that requires continuous opioid treatment and for which no alternative treatments exist. When crushed by abusers for snorting or injection, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone. Targiniq ER can still be easily abused when taken by mouth, currently the most common way oxycodone is abused. Targiniq ER is not approved for as-needed pain relief.

FDA Approves Ryanodex for the Treatment of Malignant Hyperthermia

Ryanodex was granted priority review status by the FDA in March 2014 Read More...

The U. S. Food and Drug Administration (FDA) has approved Ryanodex (dantrolene sodium), an injectable skeletal muscle relaxant indicated for the treatment of malignant hyperthermia (MH). Dantrolene sodium is the only antidote for MH. MH is an inherited and potentially fatal disorder triggered by certain anesthetic agents in genetically susceptible individuals. FDA had designated Ryanodex as an Orphan Drug in August 2013 and may be granted a seven-year Orphan Drug market exclusivity. Ryanodex can be prepared and administered in less than one minute by a single healthcare practitioner. Ryanodex will be available from drug wholesalers in August.

FDA Expands Imbruvica Uses to Include Certain Type of Leukemia

In clinical trials, patients treated with Imbruvica showed a 57 percent reduction in risk of death (overall survival) Read More...

The U.S. Food and Drug Administration (FDA) has approved an added indication for Imbruvica (ibrutinib) to include people with chronic lymphocytic leukemia (CLL) who have a deletion in chromosome 17, which can lead to a poor response to standard CLL therapies. CLL is a form of non-Hodgkin lymphoma that leads to a gradual increase in abnormal white blood cells called B lymphocytes. Although the original Imbruvica accelerated application for CLL did not receive breakthrough therapy designation, the latest indication did. Three other drugs approved to treat CLL with breakthrough status include Gazyva (obinutuzumab), Arzerra (ofatumumab), and Zydelig (idelalisib). Imbruvica was also approved last November to treat people with mantle cell lymphoma.

FDA Updates Consumers on Benefits of New Hepatitis C Treatments

Hepatitis C can now be cured with treatments that are easier to take and more tolerable Read More...

Hepatitis C is a blood-borne virus often acquired from sharing needles. Once infected with hepatitis C, nearly 8 in 10 untreated people remain infected for life, according to the Centers for Disease Control and Prevention (CDC). Hepatitis C complications can include liver cancer and end-stage liver disease. Three in four patients with chronic hepatitis C are baby boomers (born from 1945 to 1965) and should be tested with a simple blood test, as many infected people remain undiagnosed. New treatments include Sovaldi (sofosbuvir), which does not require co-administration with interferon, and three protease inhibitors -- Olysio (simeprevir), Victrelis (boceprevir) and Incivek (telaprevir).