Drug Criteria & Outcomes: New FDA Approvals

The following drugs have received final approval from the Food and Drug Administration (FDA):

Valacyclovir HCl (VALTREX) caplets by GlaxoSmithKline. The FDA has approved a supplemental new drug application for valacyclovir HCl (VALTREX) caplets for the treatment of cold sores in healthy adults, making Valacyclovir HCl the first one-day, oral antiviral medication proven to shorten the duration of a cold sore outbreak.

New indication for irbesartan (Avapro) by Bristol-Myers Squibb Co. and Sanofi-Synthelabo. The FDA has approved irbesartan (Avapro) for use in slowing the progression of kidney disease. Irbesartan is also indicated for the treatment of hypertension.

New formulation: Amoxicillin/clavulanate (Augmentin XR) Extended Release Tablets by GlaxoSmithKline. The FDA has approved amoxicillin/clavulanate (Augmentin XR) Extended Release Tablets for the treatment of adults with acute bacterial sinusitis (ABS) or community-acquired pneumonia (CAP). Specifically, amoxicillin/clavulanate Extended Release Tablets are indicated for the treatment of patients with ABS or CAP confirmed or suspected to be caused by b-lactamase-producing bacteria such as Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae with reduced susceptibility to penicillin.

Amoxicillin/clavulanate Extended Release Tablets employ bi-layer tablets that provide a release of amoxicillin and 62.5 mg of clavulanate potassium and an extended release of amoxicillin for a total of 1000 mg of amoxicillin. GlaxoSmithKline stresses that amoxicillin/ clavulanate Extended Release Tablets cannot be used to provide the same dosages as the original formulation (250 mg or 500 mg).