Otitis Media
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Sign up freeTop drugs studied for this disease
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FDA approval · 2007-11-09FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved Hikma Pharmaceuticals USA Inc.'s generic amoxicillin and clavulanate potassium under an Original Application.
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CLINICAL_TRIALS research · 2007-10-26Clinical Trial Update: The Influence of Feeding Position on Pulmonary Morbidity in Young Children [NA]
The update discusses a clinical trial assessing whether feeding position influences pulmonary morbidity in young children. The listed condit…
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FDA approval · 2007-10-17FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for Clarithromycin submitted by Sandoz Inc, granting a supplemental approval for the product.
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FDA approval · 2007-09-27FDA Approved: CEPHALEXIN — Supplemental Application (AVKARE)
FDA approved a supplemental application for Cephalexin submitted by AVKARE, indicating an approved modification to this product's label or a…
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FDA approval · 2007-09-27FDA Approved: CEPHALEXIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for Cephalexin from Teva Pharmaceuticals USA, Inc., representing an approved modification to the exi…
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FDA approval · 2007-09-07FDA Approved: CEFDINIR — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for cefdinir, updating the approved labeling for the product.
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FDA approval · 2007-08-13FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Sandoz Inc)
FDA approved Sandoz Inc's amoxicillin/clavulanate potassium as an Original Application (ANDA), granting approval for a generic antibiotic pr…
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FDA approval · 2007-07-25FDA 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.
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FDA label_change · 2007-06-05FDA Approved: BACTRIM — Supplemental Application (Sun Pharmaceutical Industries, Inc)
FDA approved a supplemental application for BACTRIM (sulfamethoxazole and trimethoprim) to modify the labeling.
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FDA approval · 2007-05-09FDA 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…
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FDA approval · 2007-05-07FDA Approved: CEFDINIR — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for CEFDINIR, a generic cefdinir product, authorizing continued/expanded ma…
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FDA approval · 2007-05-04FDA Approved: CEFDINIR — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approves Teva's original application for CEFDINIR (cefdinir), a generic cephalosporin antibiotic.
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FDA approval · 2007-04-06FDA Approved: CEFDINIR — Original Application (Sandoz Inc)
FDA approved Sandoz's original ANDA for cefdinir, a generic cephalosporin antibiotic.
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CLINICAL_TRIALS trial_result · 2007-04-06Clinical Trial Update: ParentLink: Better and Safer Emergency Care for Children
The ParentLink trial, sponsored by Boston Children's Hospital, evaluating safer emergency care for children, has completed. It enrolled pedi…
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FDA approval · 2007-03-26FDA 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…
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FDA approval · 2007-01-30FDA Approved: CEFPROZIL — Original Application (Aurobindo Pharma Limited)
The FDA approved the original application for cefprozil from Aurobindo Pharma Limited, making a generic cephalosporin antibiotic available i…
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CLINICAL_TRIALS trial_result · 2006-11-30Clinical Trial Update: Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial [NA]
This trial update reports the results of a randomized controlled trial comparing a wait-and-see antibiotic prescription strategy to immediat…
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CLINICAL_TRIALS research · 2006-11-30Clinical Trial Update: A Study of the Clinicopathologic Behaviour of the Different Types of Unsafe Chronic Otitis Media
A clinical trial investigating the clinicopathologic behavior of the different types of unsafe chronic otitis media, including cholesteatoma…
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CLINICAL_TRIALS trial_result · 2006-10-26Clinical Trial Update: The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children [Phase 4]
Phase 4 clinical trial evaluating the Ear Popper device for serous otitis media and accompanying conductive hearing loss in children.
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CLINICAL_TRIALS trial_result · 2006-09-20Clinical Trial Update: Efficacy Trial of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Vaccine Serotypes [Phase 3]
A Phase 3 efficacy trial assessed two pneumococcal conjugate vaccines (PncCRM and PncOMPC) for preventing acute otitis media due to vaccine-…
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CLINICAL_TRIALS trial_result · 2006-08-29Clinical 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.
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CLINICAL_TRIALS trial_result · 2006-08-17Clinical Trial Update: Middle Ear Disease Before Age 3, Treatment With Ear Tubes, and Literacy and Attentional Abilities at Ages 9 to 11 [NA]
This clinical trial update reports the completion of a NICHD-supported study examining whether placing ear tubes for early middle-ear diseas…
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FDA approval · 2006-06-19FDA 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…
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FDA approval · 2006-05-19FDA 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.