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Durata Therapeutics launches DALVANCE for injection in US

Durata Therapeutics has launched DALVANCE (dalbavancin) for injection in the US to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI).

The US Food and Drug Administration (FDA) had approved DALVANCE in May 2014 and it was the first drug to be approved as a Qualified Infectious Disease Product (QIDP).

The company started shipping the drug to its distributors earlier this week.

Durata CEO Paul Edick said DALVANCE’s unique dosing regimen offers a new approach to treatment of serious skin infections by allowing patients, healthcare professionals and hospitals to move beyond the standard daily or twice-daily IV antibiotic infusions.

"We are very pleased that DALVANCE is now available to millions of Americans who may benefit from this innovative treatment option for ABSSSI," Edick said.

DALVANCE is a second generation, semi-synthetic lipoglycopeptide, which includes a lipophilic side-chain added to an enhanced glycopeptide backbone.

It is the first and only IV antibiotic approved for ABSSSI treatment with a two-dose regimen of 1000mg followed one week later by 500mg, each administered over 30 minutes.

The drug shows bactericidal activity in vitro against a range of Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant, also known as MRSA, strains) and Streptococcus pyogenes, as well as certain other streptococcal species.