Osteomyelitis

• CLINICAL_TRIALS trial_result · 2013-09-18
  Clinical Trial Update: Treatment of Methicillin-sensitive Staphylococcus Aureus (MSSA) [NA]

  Clinical trial evaluating treatment of methicillin-sensitive Staphylococcus aureus (MSSA) in osteoarticular infection has completed.

• CLINICAL_TRIALS withdrawal · 2012-09-17
  Clinical Trial Update: a Randomized Controlled Trial Comparing Medical and Medical-surgical Treatment in Diabetic Foot Osteomyelitis [Phase 4]

  A Phase 4 randomized trial comparing medical versus medical-surgical treatment for diabetic foot osteomyelitis has been withdrawn.

• FDA approval · 2012-04-09
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved the original ANDA for vancomycin hydrochloride from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., enabling a g…

• FDA approval · 2011-09-23
  FDA Approved: TECHNETIUM TC 99M MEDRONATE — Supplemental Application (Jubilant DraxImage Inc., dba Jubilant Radiopharma)

  FDA approves a supplemental application for Technetium Tc-99m medronate (Medronate) from Jubilant Radiopharma, updating labeling to reflect …

• FDA approval · 2011-06-30
  FDA Approved: NAFCILLIN — Original Application (Fresenius Kabi USA, LLC)

  FDA approved the original application for Nafcillin sodium (NAFCILLIN SODIUM) as a generic injectable antibiotic from Fresenius Kabi USA, LL…

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• CLINICAL_TRIALS trial_result · 2011-06-14
  Clinical Trial Update: Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci [Phase 2]

  Phase 2 clinical trial investigating daptomycin for osteomyelitis associated with infected prosthetic caused by Staphylococci; trial complet…

• CLINICAL_TRIALS trial_result · 2011-05-18
  Clinical Trial Update: Procalcitonin Level and Kinetics in Children With Bacterial Infections

  A completed pediatric trial evaluating procalcitonin levels and their kinetics in children with various bacterial infections to explore pote…

• FDA approval · 2011-05-04
  FDA Approved: CEPHALEXIN — Supplemental Application (AvKARE)

  FDA approved a supplemental application for Cephalexin from AvKARE under ANDA 062713, authorizing continued manufacture and marketing of a C…

• FDA approval · 2011-04-20
  FDA Approved: NAFCILLIN — Original Application (Athenex Pharmaceutical Division, LLC.)

  FDA approves the original application for Nafcillin (nafcillin sodium) as a generic antibiotic from Athenex Pharmaceutical Division, LLC.

• FDA approval · 2011-02-22
  FDA Approved: CEPHALEXIN — Supplemental Application (AVKARE)

  The FDA approved a supplemental application for Cephalexin from AvKare.

• FDA approval · 2010-11-29
  FDA Approved: CEFAZOLIN — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for Cefazolin (cefazolin sodium) from Fresenius Kabi USA, LLC, updating an already approved prod…

• FDA approval · 2010-10-22
  FDA Approved: TECHNETIUM TC 99M MEDRONATE — Supplemental Application (Jubilant DraxImage Inc., dba Jubilant Radiopharma)

  FDA approved a supplemental application for Technetium Tc-99m Medronate (bone imaging agent) submitted by Jubilant DraxImage Inc., dba Jubil…

• CLINICAL_TRIALS trial_result · 2010-06-07
  Clinical Trial Update: Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers [NA]

  This clinical trial update reports on the efficacy of surgical treatment for osteomyelitis in diabetic foot ulcers. The current status of th…

• CLINICAL_TRIALS trial_result · 2009-08-21
  Clinical Trial Update: Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis. [Phase 3]

  A Phase 3 trial comparing tigecycline to ertapenem for diabetic foot infections (including an osteomyelitis substudy) has completed and resu…

• FDA approval · 2009-03-13
  FDA Approved: METRONIDAZOLE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved the original ANDA from Alembic Pharmaceuticals Limited for a generic metronidazole product.

• CLINICAL_TRIALS trial_result · 2009-01-29
  Clinical Trial Update: The Influence of Bisphosphonates in the Oral Cavity in Children

  This completed pediatric trial from Hadassah Medical Organization examined the effects of bisphosphonates on the oral cavity, including oste…

• FDA approval · 2008-12-30
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Mylan Institutional LLC)

  FDA approved the original application for vancomycin hydrochloride from Mylan Institutional LLC, marking the approval of a generic injectabl…

• FDA approval · 2008-09-22
  FDA Approved: CEPHALEXIN — Supplemental Application (AMELLA PHARMA, LLC)

  FDA approved a supplemental application for Cephalexin from Amella Pharma, LLC.

• FDA approval · 2007-07-25
  FDA Approved: CEPHALEXIN — Original Application (Chartwell RX, LLC)

  FDA approved an Original Application for generic Cephalexin by Chartwell RX, LLC, adding a generic option for this antibiotic.