#absssi

The FDA draft guidance released this week on possible contamination of tattoo ink was not concerning Whitney Donohue, 34, owner of Forget Me Not Tattoo in Billings, Montana. “I get our ink directly through the manufacturer — not at a store or through Amazon or eBay,” she said. “You never know if it’s going to be repackaged.” Tattoo artists themselves, she said, regulate the quality of ink they…

Which Antibiotic Is Overcome By Beta Lactamases

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KEY TOPICS

The over use of antibiotics is leading to a growing health threat around the world.The antibiotic-resistant bacteria Extended Spectrum Beta Lactamase (ESBL) is killing people.(More…)

Another, unexpected, consequence is the ability of bacteria to overcome the mechanisms that give antibiotics their efficacy, rendering them useless.(More…)

To overcome the limitations of…

FDA Approves TEFLARO® (ceftaroline fosamil) of Allergan for Pediatric Patients

May 31, 2016

Allergan has announced that the Food and Drug Administration(FDA) has approved the supplemental New Drug Application (sNDA) of the company named TEFLARO® (ceftaroline fosamil). This can be applied to pediatric patients 2 months of age to less than 18 years of age with acute bacterial skin and skin structure infections (ABSSSI). These include infections caused by methicillin-resistant…

Nabriva’s lefamulin, BC 3781 receives FDA fast-track status to treat CABP and ABSSSI

Nabriva’s lefamulin receives FDA fast-track status to treat CABP and ABSSS Austria-based Nabriva Therapeutics has received qualified infectious disease product (QIDP) and fast-track status designation from the US Food and Drug Administration for its lefamulin (BC 3781).

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http://www.pharmaceutical-technology.com/news/newsnabrivas-lefamulin-receives-fda-fast-track-status-to-treat-cabp-and-abss…

Durata Therapeutics Announces the U.S. Launch of DALVANCE(TM)

Last week, Durata Therapeutics, Inc. (Nasdaq:DRTX) announced that DALVANCE (dalbavancin) for injection is now available for use to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI). DALVANCE was approved by the U.S. Food and Drug Administration (FDA) on May 23, 2014 and was the first drug approved as a Qualified Infectious Disease Product (QIDP). Durata began…

FDA OK’s new skin infection treatment by Durata

Originally posted on Reuters

WASHINGTON (Reuters) – The U.S. Food and Drug Administration said on Friday it has approved a new drug to treat acute bacterial skin infections made by Durata Therapeutics Inc.

Approval of the drug, Dalvance, follows a positive recommendation by the FDA’s advisory committee, which also gave a favorable review to a rival product from Cubist Pharmaceuticals Inc. The…