New Drug Application Submitted for Investigational Antibiotic Doripenem

RARITAN, N.J., Johnson & Johnson Pharmaceutical Research & Development, L.L.C., (J&JPRD) announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for doripenem, an investigational carbapenem antibiotic for the treatment of nosocomial pneu...

NCCN Updates Infection Guidelines to Include Information About H1N1 Virus (Swine Flu)

...to the H1N1 strain as well as other seasonal or pandemic strains. Additional noteworthy updates to the NCCN Guidelines include the addition of doripenem (Doribax(R), Ortho-McNeil-Janssen Pharmaceuticals, Inc.) to the Antibacterial Agents Tables and tenofovir disoproxil fumarate (Viread(R), Gilead Scien...

FDA Extends Review Timeline for Additional Indication for Antibiotic DORIBAX(TM)

...te to the empiric selection of therapy. IMPORTANT SAFETY INFORMATION DORIBAX is contraindicated in patients with known serious hypersensitivity to doripenem or other carbapenems or in patients who have demonstrated anaphylactic reactions to beta-lactams. Serious and occasionally fatal hypersensitivity (a...

Doripenem in Medical Technology

New Data Show In Vitro Potency of Doripenem Against Resistant Bacteria

WASHINGTON, Oct. 27 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), today announced new study results that demonstrate doripenem (DORIBAX(TM), doripenem for injection), a carbapenem antibiotic, was found to be more potent in vitro against certain strai...

New Data Show Doripenem as Effective as Commonly Used Therapies in Treating Hospital-Acquired Pneumonias

CHICAGO, Sept. 18 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C., today announced that the investigational antibiotic doripenem was found to clinically cure 81% of patients with nosocomial pneumonia (NP), and 68% of patients with ventilator-associated pneumonia...

FDA Requires Additional Information on DORIBAX for Treatment of Hospital-Acquired Pneumonia

...also is approved in Europe and Russia for cIAI, cUTI and NP, including VAP. doripenem is licensed from Shionogi & Co., Ltd. INDICATIONS DORIBAX is indicated ...RIBAX is contraindicated in patients with known serious hypersensitivity to doripenem or other carbapenems or in patients who have demonstrated anaphylactic reac...

Doripenem in Biological Technology

FDA Advisory Committee Provides Opinion of DORIBAX(TM) for the Treatment of Hospital-Acquired Pneumonia

... is awaiting final approval in Europe for cIAI, cUTI and NP, including VAP. doripenem is licensed from Shionogi & Co., Ltd. INDICATIONS DORIBAX is indicated ...RIBAX is contraindicated in patients with known serious hypersensitivity to doripenem or other carbapenems or in patients who have demonstrated anaphylactic reac...

FDA Approves DORIBAX(TM) for the Treatment of Complicated Intra-Abdominal and Complicated Urinary Tract Infections

...c. through its Institutional Franchise. The use of doripenem in the treatment of hospital-acquired (nosocomial)...nder regulatory review in the U.S., and the use of doripenem for complicated intra-abdominal infections, compli...d pneumonia, is under regulatory review in Europe. doripenem is licensed from Shionogi & Co., Ltd., which launc...