SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : Oscient Pharmaceuticals Corp. (OSCI)
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
From: Ian@SI9/22/2006 8:45:57 AM
  Read Replies (1) of 1154
 
Oscient Pharmaceuticals Receives Approvable Letter from FDA for FACTIVE(R) Tablets for Five-Day Treatment of Community-Acquired Pneumonia

bwire

WALTHAM, Mass. (Business Wire) -- Oscient Pharmaceuticals (Nasdaq: OSCI) has received an
approvable letter from the U.S. Food and Drug Administration (FDA) for
the supplemental New Drug Application (sNDA) seeking approval for the
five-day treatment of community-acquired pneumonia (CAP) of mild to
moderate severity with FACTIVE(R) (gemifloxacin mesylate) tablets.
FACTIVE is currently approved for the five-day treatment of acute
bacterial exacerbations of chronic bronchitis (AECB) and the seven-day
treatment of CAP.

According to the letter, the Company is required to provide
clarification and additional interpretation regarding certain data
included in the application to assist the FDA in its evaluation. The
Company intends to provide this information to the FDA in the coming
weeks; the FDA typically responds to resubmissions within two months.
The Company believes no additional clinical trials are required.

"We look forward to working closely with the FDA to meet the
requirements of the letter," stated Steven M. Rauscher, President and
Chief Executive Officer. "As FACTIVE enters its third respiratory
tract infection season, the drug continues to be an important option
for physicians treating lower respiratory tract infections."

The submission for the five-day treatment of CAP contained data
from a successful Phase III trial completed in 2005 comparing a
five-day and seven-day treatment with FACTIVE 320 mg once-daily for
CAP in 510 patients. That study demonstrated strong clinical response
rates at follow up (the primary endpoint) in both arms. Currently, no
fluoroquinolone is approved for the five-day treatment of both AECB
and CAP. Community-acquired pneumonia is a common and serious illness
in the United States with three to four million cases per year,
resulting in approximately one million hospitalizations and 40,000
deaths annually. Pneumonia is the most common cause of death due to an
infectious disease.
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  

HomeMailHotSubjectMarksPeopleMarksKeepersSettings
Terms Of UseContact UsCopyright/IP PolicyPrivacy PolicyAbout UsFAQAdvertise on SI
© 2026 Knight Sac Media.  Data provided by Twelve Data, Alpha Vantage, and CityFALCON News