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Weekly Drug News Round-Up: June 7, 2017

Nicox Gains FDA Approval of Zerviate for Eye Allergies

The recommended dose is one drop in each affected eye twice daily Read More...

Allergic conjunctivitis is the eye's reaction to allergy-causing substances like pollen and dander, which usually includes redness, tearing, and itching of the eyes and the inner surface of the eyelids. This week, the FDA approved Zerviate (cetirizine hydrochloride ophthalmic solution, 0.24%), a histamine-1 (H1) receptor antagonist eye drop formulation for the treatment of itching linked to allergic conjunctivitis. Zerviate is the first eye drop formulation of cetirizine, also known as the brand Zyrtec. In clinical trials, significantly less eye itching was seen at 15 minutes and 8 hours after treatment compared to vehicle. Other recent allergic conjunctivitis approvals include Pazeo and Lastacaft.

FDA Clears First Generic Strattera for ADHD

ADHD affects about 5% of children, and roughly 2.5% of adults Read More...

Attention deficit hyperactivity disorder, or ADHD, is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. Strattera (atomoxetine), originally approved in 2002 from Eli Lilly, is thought to selectively inhibit norepinephrine reuptake. Strattera is now available in a cost-saving generic formulation from several manufacturers. Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs, but usually cost much less. In clinical trials for atomoxetine, common side effects included nausea, decreased appetite, and dizziness. In addition, atomoxetine has a boxed warning for the increased risk of suicidal ideation in children and adolescents.

Aristada: Every Two Month Dose Approved for Schizophrenia

Schizophrenia affects over 2.4 million U.S. adults

Schizophrenia is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well as by disorganized thinking. Aristada (aripiprazole lauroxil) from Alkermes is an extended-release injectable atypical antipsychotic formerly approved with one-month and six-week dosing options for the treatment of schizophrenia. This week, the FDA cleared a two-month dosing option, as well. Aristada now comes in four doses and three dosing duration options: 441 mg, 662 mg or 882 mg once monthly, 882 mg once every six weeks and 1064 mg once every two months, given along with oral aripiprazole for 21 days. The new dose is expected to be available in mid-June.

Drugs That Target Genetic Mutations Extending Lung Cancer Survival

Both of these genetically driven forms of lung cancer are more common in nonsmokers Read More...

As reported this week in the New England Journal of Medicine, two drugs that target genetic mutations are extending survival for patients with advanced non small cell lung cancer. The FDA-approved drug alectinib (Alecensa) works twice as long as the current standard treatment crizotinib (Xalkori) in halting cancer growth in patients with ALK-positive non-small cell lung cancer. According to experts, Alecensa may allow people to live months or years longer just by taking a daily pill. In another study, an experimental drug called dacomitinib delayed cancer growth by about half in non-small cell lung cancer patients with the epidermal growth factor receptor (EGFR), compared to gefitinib (Iressa).

From the FDA: Seasonal Allergies: Which Medication is Right for You?

Do you know what’s available to effectively treat allergy symptoms? Read More...

Allergies are often seasonal, occurring due to pollen in the spring, but can be year-round, too. A trigger - also known as an “allergen” - leads to release of histamines that can cause allergy symptoms like sneezing and itchy, watery eyes. But who wants to stay indoors when the weather has just turned warm? The FDA regulates many prescription and over-the-counter (OTC) medications to relieve allergy symptoms, such as:

And a reminder from the FDA: always read the label before buying an OTC product for you or your children. For more information, join the Allergy Support Group.