Rx Product News (October 2016)

Shire US, Inc

INDICATION: The FDA has approved Xiidra (lifitegrast ophthalmic solution) 5%, a lymphocyte function—associated antigen- 1 antagonist, for the treatment of the signs and symptoms of dry eye disease. The recommended dosage is 1 drop twice daily in each eye (approximately 12 hours apart).

DOSAGE FORM: Ophthalmic solution containing lifitegrast 5% (50 mg/mL)

FOR MORE INFORMATION: xiidra.com

AKOVAZMARKETED BY: Flamel Technologies

INDICATION: Flamel Technologies has announced the launch of Akovaz, its formulation of ephedrine sulfate for injection, which received FDA approval in April 2016. Ephedrine sulfate is administered parenterally as a pressor agent to address clinically important hypotension in surgical settings.

DOSAGE FORM: Injection: 50 mg/mL ephedrine sulfate in a single-use vial

FOR MORE INFORMATION: eclatpharma.com

ZINBRYTAMARKETED BY: Biogen and AbbVie, Inc

INDICATION: The FDA has approved Zinbryta (daclizumab), an interleukin- 2 receptor—blocking antibody, for the treatment of adult patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Zinbryta should generally be reserved for patients who have had an inadequate response to 2 or more drugs indicated for the treatment of MS.

DOSAGE FORM: Injection: 150 mg/mL solution in a single-dose prefilled syringe

FOR MORE INFORMATION: zinbryta.com

NAMZARICMARKETED BY: Allergan

INDICATION: The FDA has approved an expanded label for Namzaric (memantine and donepezil hydrochlorides) extendedrelease, a once-daily fixed-dose combination of an N-methyl-Daspartate receptor agonist and an acetylcholinesterase inhibitor. The new indication allows patients with moderate to severe Alzheimer’s disease who are stabilized on donepezil hydrochloride 10 mg once daily to start combination therapy directly with Namzaric.

DOSAGE FORM: Capsules: 7/10, 14/10, 21/10, and 28/10 mg

FOR MORE INFORMATION: namzaric.com