NAPSR news: FDA approves Cubist Pharmaceuticals Sivextro for treatment of skin infections

Cubist Pharmaceuticals, Inc announced on Friday, June 20, 2014 that the U.S. Food and Drug Administration (FDA) approved Sivextro to treat bacterial skin infections.
Spread the Word
Listed Under

* Pharmaceutical Sales
* CNPR Sales Training
* Fda Approval
* Napsr

* Biotech
* Health

* Washington - District of Columbia - US

WASHINGTON - June 23, 2014 - PRLog -- SIVEXTRO™ (tedizolid phosphate) is indicated for the treatment of acute bacterial skin infections (ABSSSI) caused by vulnerable isolates of Gram-positive pathogens, which includes: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius and Streptococcus constellatus), and Enterococccus faecalis. Methicillin-resistant Staphylococcus aureus (MRSA) is known to be resistant to other antibiotic treatments. In the community, most MRSA infections are skin infections which pose a serious public health threat according to the US Centers for Disease Control and Prevention (CDC).

The new drug application (NDA) for SIVEXTRO was sustained by two global Phase 3 studies. These studies confirmed that SIVEXTRO 200 mg administered once daily for six days was statistically non-inferior to 600 mg of linezolid taken twice a day for 10 days. SIVEXTRO is one of the first medicines approved in the U.S. that the FDA selected as a Qualified Infectious Disease Product (QIDP) for its indication, ABSSSI, according to the Generating Antibiotic Incentives Now (GAIN) Act of 2012. SIVEXTRO qualifies for certain incentives related to the development of new antibiotics, including a five year extension of Hatch-Waxman exclusivity.

“We are pleased by the FDA approval of SIVEXTRO, which provides a new option for physicians to treat patients with serious bacterial skin infections, including those caused by MRSA,” said Michael Bonney, Chief Executive Officer of Cubist. “SIVEXTRO provides physicians with flexibility to transition patients from I.V. to oral treatment as required. The oral option provides opportunity for out-patient care, which could reduce the need for costly hospitalization

“MRSA is still problematic in the U.S. and is responsible for the deaths of more than 11,000 Americans each year,” said Ralph Corey, M.D., Professor of Medicine and Infectious Disease, Duke Clinical Research Institute and Duke University Medical Center. “Not every antibiotic will work for every patient and more drug options are an imperative. Physicians should evaluate the use of SIVEXTRO. A six-day course of therapy with the option to choose—and, if needed—change from I.V. to oral administration is a welcome new development.”

The treatment options available for SIVEXTRO will certainly be valuable to patients who are inflicted with these debilitating infections.


With such industry leaders paving the way with new beneficial therapeutic breakthroughs, they will need both certified and qualified individuals to promote their product. When industry leaders look for new candidates for sales/marketing positions, they look toward individuals that are industry trained. Companies are looking for people that have the background to sell their product both proficiently and efficiently.


The CNPR® represents a level of industry achievement and a demonstrated knowledge of pharmacology, medical terminology, pharmaceutical selling guidelines, physician selling techniques and industry standards. Pharmaceutical sales candidates who have this training will differentiate themselves from other individuals looking for open positions. Upon successful completion of the training each student will receive the Certification Mark of the CNPR®. CNPR® graduates should immediately utilize the NAPSRx® Career Center to apply for pharmaceutical sales positions.

The CNPR is a federally trademarked certification you can earn by demonstrating the necessary knowledge in pharmacology, medical terminology, physiology, and regulations for selling pharmaceuticals. The CNPR examination is dedicated to increasing the professional level of NAPSR members and to developing meaningful and ethical standards fully accepted by both its members and members of the pharmaceutical community.

Individuals that are interested in becoming a Certified National Pharmaceutical Representative (CNPR) can contact the National Association of Pharmaceutical Sales Representatives(NAPSRx) for more information.

Email:*** Email Verified
Tags:Pharmaceutical Sales, CNPR Sales Training, Fda Approval, Napsr
Industry:Biotech, Health
Location:Washington - District of Columbia - United States
Account Email Address Verified     Account Phone Number Verified     Disclaimer     Report Abuse
Page Updated Last on: Jun 23, 2014
Daily News
Weekly News

Like PRLog?
Click to Share