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Weekly Drug News Round Up - March 19, 2014

Impavido FDA-Approved for Tropical Disease Leishmaniasis

The FDA granted Impavido fast track designation, priority review, and orphan product designation Read More...

The U.S. Food and Drug Administration (FDA) today approved Paladin Therapeutics' Impavido (miltefosine) to treat a parasitic tropical disease called leishmaniasis in patients 12 years of age and older. Leishmaniasis is acquired through the bite of a sandfly. Impavido is an oral medicine for the three main types of leishmaniasis: visceral, cutaneous, and mucosal leishmaniasis. Impavido is the first FDA-approved drug to treat cutaneous or mucosal leishmaniasis. Impavido is generally is well-tolerated, with gastrointestinal (stomach) side effects like nausea, vomiting, diarrhea most commonly reported. The labeling for Impavido includes a boxed warning that the drug can cause fetal harm and therefore should not be given to pregnant women.

FDA Approves Mallinckrodt’s Xartemis XR

Xartemis XR is indicated for patients who do not receive adequate pain relief with non-opioid analgesics Read More...

The U.S. Food and Drug Administration (FDA) has approved Xartemis XR (oxycodone hydrochloride and acetaminophen) 7.5/325 mg Extended-Release Tablets for the management of acute, severe pain. The approval is based, in part, on the Phase 3 efficacy study conducted in an acute post-surgical pain model. Xartemis XR has both immediate- and extended-release components and is formulated to provide onset of pain relief in less than one hour with twice daily dosing. Xartemis XR is the only extended-release opioid on the market that contains both oxycodone and acetaminophen.

Hemangeol Approved for Infantile Hemangioma

Infantile hemangioma is the most common vascular benign tumor of infancy, affecting 3 to 10 percent of newborns Read More...

Infantile hemangioma is a benign tumor characterized by abnormal growth of the endothelial tissue usually on the head or neck. The U.S. Food and Drug Administration (FDA) approved Hemangeol (propranolol hydrochloride), which is the first and only approved systemic treatment for proliferating infantile hemangioma. Treatment over 6 months resulted in a 60 percent success rate versus 3.6 percent in the placebo group (p< 0.0001) and resulted in complete or nearly-complete resolution of the target hemangioma. However, retreatment was required in 11.4 percent of patients after stopping Hemangeol.

Upsher-Smith’s Qudexy XR Approved For Seizures

The manufacturer states Qudexy XR will be available to patients in the second quarter of 2014 Read More...

The U.S. Food and Drug Administration (FDA) has approved Qudexy XR (topiramate), an antiepileptic drug indicated as initial monotherapy in patients 10 years and older with partial-onset seizures (POS) or primary generalized tonic clonic seizures. Qudexy XR is also approved as adjunctive therapy in patients 2 years and older with POS, primary generalized tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome. Qudexy XR will be available in 25, 50, 100, 150, and 200-milligram extended-release capsules, given once a day.

Eliquis Receives New Indication for DVT Prophylaxis

Eliquis is currently approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Read More...

The U.S. Food and Drug Administration (FDA) has approved Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. In December 2013, the FDA accepted for review another sNDA for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE. Eliquis is taken twice a day and lower doses are needed if the patient has 2 of the following 3 characteristics: kidney impairment, low weight, or 80 years or older.