Sinusitis

• CLINICAL_TRIALS trial_result · 2008-01-14
  Clinical Trial Update: Postoperative Treatment After Endoscopic Sinus Surgery [NA]

  A completed clinical trial evaluating postoperative treatment after endoscopic sinus surgery for sinusitis.

• FDA approval · 2008-01-07
  FDA Approved: CEFDINIR — Original Application (BluePoint Laboratories)

  FDA approves an Abbreviated New Drug Application for cefdinir from BluePoint Laboratories, indicating the availability of a generic cefdinir…

• CLINICAL_TRIALS trial_result · 2007-11-30
  Clinical Trial Update: Amphotericin B Suspension in Refractory Chronic Sinusitis [Phase 3]

  A Phase 3 trial evaluating amphotericin B suspension for refractory chronic sinusitis has completed.

• CLINICAL_TRIALS trial_result · 2007-10-31
  Clinical Trial Update: Outcomes of Patients Not Responding to Antibiotics in the Community [NA]

  Update on outcomes for patients in the community who did not respond to antibiotics.

• CLINICAL_TRIALS trial_result · 2007-10-19
  Clinical Trial Update: Middle Meatal Bacteriology During Acute Respiratory Infection in Children [Phase 4]

  Phase 4 clinical trial update studying middle meatal bacteriology during acute respiratory infections in children. The study also includes s…

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• FDA approval · 2007-09-06
  FDA Approved: GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE — Supplemental Application (WALGREEN COMPANY)

  FDA approved Walgreens' supplemental application for Guaifenesin and Pseudoephedrine Hydrochloride.

• EMA withdrawal · 2007-07-26
  EMA Application withdrawn: Garenoxacin mesylate — Schering-Plough Europe

  The EMA application for garenoxacin mesylate by Schering-Plough Europe was withdrawn.

• FDA label_change · 2007-06-05
  FDA Approved: BACTRIM — Supplemental Application (Sun Pharmaceutical Industries, Inc)

  FDA approved a supplemental application for BACTRIM (sulfamethoxazole and trimethoprim) to modify the labeling.

• FDA approval · 2007-05-09
  FDA Approved: CEFDINIR — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's cefdinir product CEFDINIR under an Original Application (ANDA). This generic antibiotic is approved for common infection…

• FDA approval · 2007-05-07
  FDA Approved: CEFDINIR — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for CEFDINIR, a generic cefdinir product, authorizing continued/expanded ma…

• FDA approval · 2007-04-06
  FDA Approved: CEFDINIR — Original Application (Sandoz Inc)

  FDA approved Sandoz's original ANDA for cefdinir, a generic cephalosporin antibiotic.

• FDA approval · 2007-03-26
  FDA Approved: AMOXICILLIN — Original Application (Sandoz Inc)

  FDA approved Sandoz Inc's original application for amoxicillin, making a generic amoxicillin product available. The approval supports its us…

• FDA approval · 2006-12-19
  FDA Approved: SINUS AND COLD D — Supplemental Application (Meijer Distribution Inc)

  FDA approves a supplemental ANDA for Sinus and Cold D, a combination product containing naproxen sodium and pseudoephedrine hydrochloride di…

• CLINICAL_TRIALS trial_result · 2006-08-29
  Clinical Trial Update: A Trial of Point of Care Information in Ambulatory Pediatrics [Phase 3]

  A Phase 3 clinical trial evaluating a point-of-care information tool in ambulatory pediatrics has completed.

• FDA approval · 2006-08-23
  FDA Approved: MUCINEX — Supplemental Application (RB Health (US) LLC)

  FDA approved a supplemental application for Mucinex (guaifenesin) from RB Health (US) LLC, indicating FDA action on a supplemental submissio…

• CLINICAL_TRIALS trial_result · 2006-07-13
  Clinical Trial Update: Hemostatic Matrix in Endoscopic Sinus Surgery [Phase 4]

  A Phase 4 clinical trial evaluating Hemostatic Matrix in endoscopic sinus surgery has completed.

• FDA approval · 2006-06-19
  FDA Approved: AMOXICILLIN — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc. to market amoxicillin under an Original Application (ANDA). The approval covers a generic amoxic…

• FDA approval · 2006-05-19
  FDA Approved: CEFDINIR — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin's generic cefdinir (CEFDINIR) under an Original Application (ANDA065264), providing a new generic cephalosporin option.