Recent FDA action (through April 2012) related to, Dihydroergotamine, Levadex inhalation aerosol, droxidopa, Northera, Amitriptyline 4% ketamine 2% cream, AmiKet, Afilbercept, ZALTRAP, Nav rAAV8 vector, Carbamazepine, Carbatrol, Vancomycin hydrochloride, Vancocin, Irbesartan, irbesartan-hydrochloriderothiazide, Avapro, Avalide, Fluvastatin, Lescol
Complete response
Fast-track designation
Priority review
First-time generic approvals
Carbamazepine extended-release capsules in 100-mg, 200-mg, and 300-mg strengths (equiv to Carbatrol)
PRASCO LABORATORIES
Vancomycin hydrochloride, USP Capsules (equiv to Vancocin)
VIROPHARMA
Irbesartan and irbesartan-hydrochlorothiazide tablets (equiv to Avapro and Avalide tablets)
TEVA
Fluvastatin capules USP, 20-mg and 40-mg strengths (equiv to Lescol)
MYLAN
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).