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Weekly Drug News Round-Up: March 16, 2016

Spectrum’s Evomela Injection Approved for Multiple Myeloma

Evomela approval is the first new formulation of melphalan since 1964 Read More…

Evomela (melphalan) is an alkylating agent used in the treatment of patients with multiple myeloma (MM). MM is a malignancy of the plasma cells in the bone marrow, resulting in bone marrow failure and destruction. This week, the US Food and Drug Administration (FDA) approved Evomela for use as a high-dose conditioning treatment prior to stem cell transplantation in patients with MM, and for the palliative treatment of patients with MM for whom oral therapy is not appropriate. This is the first product to be FDA-approved for the high-dose conditioning indication in MM. Evomela has also received Orphan Drug Designation.

Teva’s First-Time Generic Viagra Wins FDA Approval

It is estimated roughly 30 million men in the U.S. suffer from ED Read More...

Viagra is one of the most recognizable prescription drug names on the US market. In 1998, the FDA approved Viagra (sildenafil), the first oral treatment for erectile dysfunction. Often called "the little blue pill", Viagra was the first phosphodiesterase 5 (PDE5) inhibitor approved to treat erectile dysfunction (ED), a common sexual problem for men that increases with age. Last week, FDA approved Teva Pharmaceutical’s sildenafil citrate tablets, the generic for Viagra in 25, 50, and 100 mg strengths. Teva has 180-day exclusivity which means that other generic manufacturers cannot market sildenafil during that time period.

Xalkori Use Expanded to Include a Form of Rare Lung Cancer

Lung cancer is the most common cancer globally and leads to 1 in 5 cancer deaths Read More...

Pfizer’s Xalkori (crizotinib) was first FDA-approved in 2011 to treat advanced non-small cell lung cancer (NSCLC) in patients with anaplastic lymphoma kinase (ALK)-positive tumors. Xalkori, an oral tyrosine kinase inhibitor, is now also approved to treat patients whose tumors are ROS proto-oncogene 1 (ROS1)-positive. In clinical studies in patients with ROS-1-positive NSCLC, roughly two-thirds of participants treated with Xalkori had their tumors partially or completely shrink for an average of 18 months. The drug's most common side effects include nausea, diarrhea, vomiting, swelling, constipation, elevated liver enzymes, fatigue, loss of appetite and upper respiratory infection.

CDC Publishes Opioid Guidelines for Chronic Pain

The facts are alarming: more than 40 Americans die each day from prescription opioid overdoses Read More...

In response to the opioid overdose public health emergency in the US, yesterday the Centers for Disease Control and Prevention (CDC) released guidelines for prescribing opioids for chronic pain. This tool is meant to help primary care providers appropriately prescribe effective and safe treatments for chronic pain in the outpatient setting. Opioids include widely prescribed drugs such as Vicodin, Oxycontin, and Lorcet. Chronic pain, as opposed to acute pain, usually lasts longer than 3 months, and past the normal time for healing. The guideline focuses on substituting the use of other effective treatments available for chronic pain, such as nonopioid medications like NSAIDs or non-pharmacologic therapies.

Not All Patients With Stroke Risk Receiving Treatment: Study

One-quarter of all Americans over age 40 are at risk for developing atrial fibrillation Read More...

Atrial fibrillation, a heart rhythm disorder, increases the risk for stroke and patients often receive blood thinners to help decrease this complication. However, the latest research published in JAMA Cardiology suggests many patients who are candidates for therapy are not receiving treatment. Researchers said guidelines should be followed that include blood thinners like warfarin. Cardiologists may be placing too much emphasis on the risk for bleeding, but for most patients the benefits are worth the risk, according to the authors. In addition to warfarin (Coumadin), prescribed blood thinners in the US include Pradaxa (dabigatran), Xarelto (rivaroxaban) and Eliquis (apixaban).