Companies
AstraZeneca Pharmaceuticals LP, Wilmington, DE, has submitted a supplemental New Drug Application (sNDA) with the Food and Drug Administration (FDA) to add treatment of complicated skin and skin structure infections to the indications for its antibiotic, MERREM IV (meropenem for injection). MERREM is currently indicated in the United States as a single-agent therapy for the treatment of intra-abdominal infections and bacterial meningitis.
The sNDA submission is based on results from an international Phase III, randomized, double-blind, multicenter trial involving more than 1000 patients with a range of complicated skin and skin structure infections, as well as a clinical pharmacokinetic study.
Complicated skin and skin structure infections involve deep wounds, such as surgical incisions, bites and lacerations, major abscesses, and infected skin ulcers. These include complicated cellulitis, surgical and traumatic wound infections, infected diabetic and vascular ischemic ulcers, and other skin and skin structure infections requiring surgery or IV antibiotic therapy.
Information: http://www.astrazeneca-us.com
The US Senate and US House of Representatives have passed the 2005 Defense Appropriations Conference Report, which includes $1 million for the development of BioFoam, a protein hydrogel adhesive in the preclinical stage of development, by CryoLife, Inc, Atlanta, GA. BioFoam contains an expansion agent and sets quickly while expanding, providing an opportunity to stop bleeding of large vessel injuries and seal the wound. The product is being developed for use on the battlefield to treat gunshot and mortar wounds.
Information: http://www.cryolife.com
ALZA Corporation, Mountain View, CA, has received an approvable letter from the US Food and Drug Administration regarding a new drug application for IONSYS, which is an iontophoretic, fentanyl-containing, transdermal analgesic. ALZA is a member of the Johnson & Johnson family.
Information: http://www.jnj.com
SenTech Medical Systems, Ft. Lauderdale, FL, has received registration to both ISO 13485-2003/Canadian Medical Device Conformity Assessment System and ISO 9001-2000. The 5-day registration assessment was conducted by BSI, a leading quality management system registrar. SenTech demonstrated it was in compliance with the requirements of each standard.
Achieving registration to these quality standards and satisfying regulatory requirements for Europe and Canada is a significant accomplishment for the SenTech team, stated Abbey Daniels, SenTech's Chief Executive Officer.
Information: http://www.sentechmedical.com