Rx Product News

Pharmacy Times, December 2013 Heart Health, Volume 79, Issue 12

Our round-up of new prescription products.

Marketed by: Iroko Pharmaceuticals, LLC

Indication: The FDA has approved Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug, for the treatment of mild to moderate acute pain in adults. The recommended dosage is 18 or 35 mg orally 3 times a day. The lowest effective dosage for the shortest duration consistent with individual patient treatment goals should be used. Zorvolex capsules are not interchangeable with other formulations of oral diclofenac even if the milligram strength is the same.

Dosage Form: Capsules: 18 or 35 mg

For More Information: https://www.zorvolex.com

Khedezla

Marketed by: Osmotica Pharmaceutical Corp

Indication: The FDA has approved Khedezla (desvenlafaxine) extended-release tablets, a serotonin and norepinephrine reuptake inhibitor, for the treatment of major depressive disorder. Khedezla is not approved for use in pediatric patients. The recommended dosage is 50 mg once daily with or without food. The tablets should be taken whole. For discontinuation, the dose should be reduced gradually when possible.

Dosage Form: Extended-release tablets: 50 and 100 mg

For More Information: www.accessdata.fda.gov/drugsatfda_docs/label/2013/204683s001lbl.pdf

Mekinist

Marketed by: GlaxoSmithKline

Indication: The FDA has approved Mekinist (trametinib), a kinase inhibitor, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test. Mekinist is not indicated for the treatment of patients who have received prior BRAF-inhibitor therapy. The recommended dosage is 2 mg orally once daily, at least 1 hour before or at least 2 hours after a meal.

Dosage Form: Tablets: 0.5, 1, and 2 mg

For More Information: www.mekinist.com

Tafinlar

Marketed by: GlaxoSmithKline

Indication: The FDA has approved Tafinlar (dabrafenib), a kinase inhibitor, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation, as detected by an FDA-approved test. Tafinlar is not indicated for treatment of patients with wild-type BRAF melanoma. The recommended dosage is 150 mg orally twice daily, at least 1 hour before or at least 2 hours after a meal.

Dosage Form: Capsules: 50 or 75 mg

For More Information: www.tafinlar.com