08:00 , Jan 2, 2012 |  BC Week In Review  |  Company News

Covis, GlaxoSmithKline sales and marketing update

GlaxoSmithKline granted Covis U.S. and Puerto Rican rights to commercialize antibiotics Fortaz ceftazidime and Zinacef cefuroxime, cardiovascular drug Lanoxin digoxin , depression drug Parnate tranylcypromine sulfate and gastrointestinal drug Zantac Injection ranitidine hydrochloride. GSK will...
08:00 , Oct 30, 2006 |  BioCentury  |  Regulation

The ABS comparisons

The ABS comparisons Study Treatment Clinical cure rate at TOC visit in clinically evaluable population Lower limit 95% CI (A) Clinical cure rate at TOC visit in ITT population Lower limit 95% CI (A) 100288...
08:00 , Oct 30, 2006 |  BioCentury  |  Regulation

On the market

On the market Product Class Amoxil amoxicillin (GlaxoSmithKline) Beta-lactam Augmentin amoxicillin/clavulanate (GlaxoSmithKline) Beta-lactam Omnicef cefdinir (Abbott) Beta-lactam Ceftin cefuroxime (GlaxoSmithKline) Beta-lactam Cefzil cefprozil (Bristol-Myers) Beta-lactam Vantin cefpodoxime (Pfizer) Beta-lactam Avelox moxifloxacin (Bayer) Fluoroquinolone Cipro ciprofloxacin...
08:00 , Oct 30, 2006 |  BioCentury  |  Regulation

Up next

Up next Company Product Description Indication Status Primary endpoint (Ph III) Advanced Life Sciences Cethromycin Ketolide antibiotic CAP (A) Ph III (CAP) Non-inferiority to clarithromycin GlaxoSmithKline Altabax retapamulin Topical pleuromutilin antibiotic SSSI PDUFA date (December)...
08:00 , Oct 30, 2006 |  BioCentury  |  Regulation

Antibiotic resistance

FDA's rejection of Replidyne Inc. 's faropenem medoxomil has removed nearly all doubt the agency has resolved a long-running internal debate over the acceptability of non-inferiority studies to support efficacy in most community-acquired bacterial infections....
07:00 , Sep 18, 2006 |  BioCentury  |  Product Development

Non-inferiority in ABS

Non-inferiority in ABS Company Product Endpoint supporting approval Timing of measurements Status Beta Lactam Replidyne/Forest Orapem (Faropenem) medoxomil Non-inferiority comparison w/ cefuroxime axetil (A) Test of cure visit (days post-treatment N/A) Oct. 20 PDUFA Macrolide...
07:00 , Jun 12, 2006 |  BC Week In Review  |  Clinical News

Ketek telithromycin: Phase III suspended enrollment

SAN said it voluntarily suspended enrollment in a pediatric trial for Ketek to await FDA confirmation that the development program is consistent with the agency’s "current thinking" on development of anti-infectives in children. A double-blind,...
07:00 , Oct 17, 2005 |  BC Week In Review  |  Clinical News

Factive gemifloxacin mesylate: Phase III data

Data from a retrospective analysis of 10 Phase III trials in 5,378 patients showed that Factive was similar to comparators at the end of therapy with success rates of about 90%. Factive was more effective...
07:00 , Oct 17, 2005 |  BC Week In Review  |  Clinical News

Factive gemifloxacin mesylate: Phase III data

In a retrospective analysis of 4 Phase III trials in 1,969 patients, Factive was more effective than cefuroxime and trovafloxacin. In the 301 patients with allergic rhinitis, response rates were 89.3% for Factive vs. 77%...
08:00 , Nov 3, 2003 |  BioCentury  |  Strategy

Ranbaxy's top sellers

Ranbaxy's top sellers Product Therapeutic area 2002 sales Axetil cefuroxime Anti-infectives $115.0 Mox/Ranoxyl amoxicillin Anti-infectives $45.5 Sporidex cephalexin Anti-infectives $44.3 Histac ranitidine Gastrointestinal $31.9 Cifran/Rancif ciprofloxacin Anti-infectives $30.4 Enhancin/Mox-clav co- amoxyclav (penicillin) Anti-infectives $21.1 Keflor/Vercef...