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Monthly News Roundup - July 2014

GSK’s Flonase Allergy Relief Approved for OTC Use

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

In an extra effort to combat the rampant 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). Targiniq ER is 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

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, an inherited and potentially fatal disorder triggered by certain anesthetic agents in genetically susceptible individuals. FDA had previously designated Ryanodex as an Orphan Drug in August 2013 and may grant 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.

Gilead’s Zydelig Approved as Fifth Breakthrough Therapy

The U.S. Food and Drug Administration (FDA) has approved Zydelig (idelalisib) to treat patients with three types of blood cancers: relapsed chronic lymphocytic leukemia (CLL), relapsed follicular B-cell non-Hodgkin lymphoma (FL), and relapsed small lymphocytic lymphoma (SLL). In clinical trials, patients with relapsed CLL who were treated with orphan drug Zydelig and Rituxan lived 10.7 months without disease progression compared to roughly 5.5 months for patients treated with placebo and Rituxan. The FDA has approved two other breakthrough therapies for CLL in the last 9 months: Gazyva (obinutuzumab) and Imbruvica (ibrutinib). In April 2014, Arzerra (ofatumumab) was also given a green light for CLL.

Rasuvo Auto-Injector Approved for Rheumatoid Arthritis

The U.S. Food and Drug Administration (FDA) has approved Rasuvo, an injectable form of methotrexate okayed for rheumatoid arthritis (RA), polyarticular-course juvenile idiopathic arthritis (pJIA) and psoriasis. Methotrexate (MTX) has been used for over 30 years, and remains the most commonly prescribed drug for treating RA. MTX is recommended by the American College of Rheumatology as a first-line therapy for RA patients. MTX is also available in an oral tablet and intramuscular injection formulation for RA. Rasuvo is manufactured by Medac Pharma, Inc. and will be available in 10 dosage strengths, ranging from 7.5 milligrams (mg) to 30 mg in 2.5 mg increments.

Posted: July 2014