New and Generic Drug Approvals

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New and Generic Drug Approvals

April 11, 2013

Drug Name Active IngredientDosage Form/Route SponsorSubmission Type
Amrix cyclobenzaprine hydrochlorideCapsule, Extended Release; Oral Ivax IntlLabeling Revision
Doryx doxycycline hyclateTablet, Delayed Release; Oral Mayne PharmaEfficacy Supplement with Clinical Data to Support
Doryx doxycycline hyclateTablet, Delayed Release; Oral Mayne PharmaManufacturing Change or Addition
Exidine chlorhexidine gluconateAerosol, Metered; Topical XttriumLabeling Revision
Flexeril cyclobenzaprine hydrochlorideTablet; Oral Janssen Res and DevLabeling Revision
Ovidrel choriogonadotropin alfaInjectable; Injection Emd SeronoManufacturing Change or Addition
Ovidrel choriogonadotropin alfaInjectable; Subcutaneous Emd SeronoManufacturing Change or Addition
Sitagliptin Phosphate sitagliptin phosphateTablet; Oral Sun Pharma GlobalTentative Approval
Topicort desoximetasoneSpray; Topical Taro PharmaApproval
Trelstar triptorelin pamoateInjectable; Intramuscular Watson LabsManufacturing Change or Addition
Trelstar triptorelin pamoateInjectable; Intramuscular Watson LabsManufacturing Change or Addition
Trelstar triptorelin pamoateInjectable; Intramuscular Watson LabsManufacturing Change or Addition
Xeomin incobotulinumtoxinaInjectable; Injection Merz PharmsLabeling Revision
Zenpep pancrelipase (amylase;lipase;protease)Capsule, Delayed Release; Oral Aptalis Pharma UsLabeling Revision
Zinecard dexrazoxane hydrochlorideInjectable; Injection Pharmacia and UpjohnManufacturing Change or Addition

 

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