Rx Product News (September 2016)

UCB, Inc

INDICATION: The FDA has approved Briviact (brivaracetam) as an adjunctive treatment for partial-onset seizures in patients 16 years and older with epilepsy. The recommended starting dosage is 50 mg twice daily. Based on individual patient tolerability and therapeutic response, the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day).

DOSAGE FORM: Tablets: 10, 25, 50, 75, and 100 mg; oral solution: 10 mg/mL; injection: 50 mg/5 mL single-dose vial

FOR MORE INFORMATION: briviact.com

DALVANCEMARKETED BY: Allergan

INDICATION: The FDA has approved Allergan’s supplemental new drug application to update the label for Dalvance (dalbavancin). The expanded label will allow for single-dose treatments administered as a 30-minute IV infusion to treat acute bacterial skin and skin structure infections caused by Gram-positive bacteria in adults.

DOSAGE FORM: For injection: 500 mg of lyophilized powder in a vial for reconstitution

FOR MORE INFORMATION: dalvance.com

SYNJARDYMARKETED BY: Boehringer Ingelheim Pharmaceuticals, Inc

INDICATION: The FDA has approved an expanded indication for Synjardy (empagliflozin and metformin hydrochloride) to include treatment-naïve adults. Synjardy is designed to be an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both empagliflozin and metformin is appropriate. The starting dose should be individualized based on the patient’s current regimen.

DOSAGE FORM: Tablets: 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg

FOR MORE INFORMATION boehringer-ingelheim.com

FLUCELVAXMARKETED BY: Seqirus, Inc

INDICATION: The FDA has approved Flucelvax Quadrivalent (Influenza Vaccine) for use in individuals 4 years and older. Flucelvax Quadrivalent is an inactivated vaccine indicated for the prevention of influenza caused by influenza virus subtypes A and B contained in the vaccine.

DOSAGE FORM: Suspension for injection supplied in 0.5-mL single- dose prefilled syringes

FOR MORE INFORMATION: flucelvax.com