Rx Product News (July 2016)

OPDIVOMARKETED BY: Bristol-Myers Squibb

INDICATION: The FDA has granted breakthrough therapy designation to Opdivo (nivolumab) as a potential treatment for recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum-based therapy. The FDA’s decision was based on data from a phase 3, open-label, randomized trial that evaluated Opdivo compared with the investigator’s choice of therapy in patients with SCCHN with tumor progression within 6 months of platinum therapies.

DOSAGE FORM: Injection: 40 mg/4 mL and 100 mg/10 mL in a single-use vial

FOR MORE INFORMATION: opdivo.com

XTAMPZA ERMARKETED BY: Collegium Pharmaceutical, Inc

INDICATION: The FDA has approved Xtampza ER, an opioid agonist, for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Xtampza ER is Collegium’s first product utilizing its proprietary DETERx technology platform and is designed to provide adequate pain control while maintaining its extended- release drug release profile after being subjected to common methods of abuse and accidental misuse. For the full dosing recommendations, see the prescribing information.

DOSAGE FORM: Extended-release capsules: 9, 13.5, 18, 27, and 36 mg

FOR MORE INFORMATION: collegiumpharma.com

PROAIR RESPICLICKMARKETED BY: Teva Pharmaceutical Industries, Ltd

INDICATION: The FDA has approved ProAir RespiClick (albuterol sulfate) inhalation powder for the treatment or prevention of bronchospasm in children aged 4 to 11 years with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. ProAir RespiClick is a dry powder inhaler that meters 117 mcg of albuterol sulfate (equivalent to 97 mcg of albuterol base) from the device reservoir and delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the mouthpiece per actuation.

DOSAGE FORM: Inhalation powder

FOR MORE INFORMATION: myproair.com/respiclick

AMELUZMARKETED BY: Biofrontera

INDICATION: The FDA has approved Ameluz for the treatment of actinic keratosis of mild to moderate intensity on the face and scalp. Ameluz should only be administered under the supervision of a physician, a nurse, or other health care professional experienced in the use of photodynamic therapy.

DOSAGE FORM: Gel: 2 g

FOR MORE INFORMATION: biofrontera.com