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Weekly Drug News Round-Up: February 10, 2016

Promius Pharma's Topical Corticosteroid Sernivo WIns FDA Approval

Plaque psoriasis consists of inflamed and scaly skin lesions common on the elbows, knees, scalp and lower back Read More...

This week, the FDA approved Sernivo Spray (betamethasone dipropionate), a topical corticosteroid indicated for the treatment of mild to moderate plaque psoriasis in adults. In clinical studies, subjects applied Sernivo Spray or the vehicle spray to affected areas twice a day for 28 days. At day 29, Sernivo achieved success in 35 to 43 percent of patients, compared to 12 to 14 percent of those applying the vehicle. Common side effects observed during clinical trials include pruritus, burning and/or stinging, pain, and atrophy at the application site.

FDA Approves Dexilant SoluTab for GERD

GERD affects about 20 percent of the U.S. population Read More...

Gastroesophageal reflux disease (GERD) is often characterized by frequent and persistent heartburn two or more days a week despite treatment and diet changes. The FDA has approved a new dosage form for dexlansoprazole, Dexilant SoluTab, a proton pump inhibitor (PPI) indicated for the treatment of patients with heartburn associated with GERD and the maintenance of healed erosive esophagitis (EE) and relief of heartburn in adults 18 years and older. The new dosage form may aid patients who have trouble swallowing capsules. Takeda’s Dexilant capsule form was first approved in 2009 and is also indicated for the healing of erosive esophagitis (EE).

Daklinza Treatment Population for Hepatitis C Virus Expanded

Daklinza is currently the only 12-week, once-daily all-oral treatment option for chronic HCV genotype 3 Read More...

Daklinza (daclatasvir) was originally approved in July 2015 for the treatment of genotype 3 chronic hepatitis C virus (HCV) with sofosbuvir (Sovaldi) in adults. Now the FDA has expanded Daklinza’s use to include use in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3. In addition, the new indication includes hard to treat HCV patients such as those with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. In the ALLY-2 clinical trial in HIV/HCV genotype 1, treatment-naïve patients, sustained virologic response at 12 weeks (SVR12), considered a cure, ranged from 95 to 100 percent. Common side effects included fatigue (15%), nausea (9%), headache (8%) and diarrhea (7%).

Investigational Agent Shows Promise for Severe Sinusitis With Nasal Polyps

Dupilumab has already shown promise as a treatment for both severe asthma and the skin rash known as eczema Read More...

An investigational drug, injectable dupilumab, is showing promise in the treatment of patients with severe forms of sinusitis with nasal polyps. As published in this week in the Journal of the American Medical Association (JAMA), current treatments -- including nasal and oral corticosteroids and sinus surgery -- may not be optimal. In a small, placebo-controlled study with 51 subjects, researchers found that dupilumab caused a significant and lasting elimination of polyps, and/or reduction in size, comparable to treatment with oral corticosteroids. Improved sense of smell, lowered nasal congestion, and improved sleep were also documented.

FDA: 5 Tips for Traveling to the U.S. With Medications

In most cases, it’s illegal for people to import drugs into the United States for personal use Read More...

If you’re traveling abroad, or have friends or family that are visiting you here in the U.S., questions may arise about safe and legal access of prescription and over-the-counter medications. What should travelers and visitors know about bringing medications into the U.S.? What if there’s a generic available overseas but not here? Can you ship or mail a prescription medication to the U.S.? What are the regulations on bringing controlled substances into the U.S. from a foreign country? FDA answers these questions and more in this week’s FDA Consumer Articles.

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