New and Generic Drug Approvals

New and Generic Drug Approvals

April 11, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Amrix	cyclobenzaprine hydrochloride	Capsule, Extended Release; Oral	Ivax Intl	Labeling Revision
Doryx	doxycycline hyclate	Tablet, Delayed Release; Oral	Mayne Pharma	Efficacy Supplement with Clinical Data to Support
Doryx	doxycycline hyclate	Tablet, Delayed Release; Oral	Mayne Pharma	Manufacturing Change or Addition
Exidine	chlorhexidine gluconate	Aerosol, Metered; Topical	Xttrium	Labeling Revision
Flexeril	cyclobenzaprine hydrochloride	Tablet; Oral	Janssen Res and Dev	Labeling Revision
Ovidrel	choriogonadotropin alfa	Injectable; Injection	Emd Serono	Manufacturing Change or Addition
Ovidrel	choriogonadotropin alfa	Injectable; Subcutaneous	Emd Serono	Manufacturing Change or Addition
Sitagliptin Phosphate	sitagliptin phosphate	Tablet; Oral	Sun Pharma Global	Tentative Approval
Topicort	desoximetasone	Spray; Topical	Taro Pharma	Approval
Trelstar	triptorelin pamoate	Injectable; Intramuscular	Watson Labs	Manufacturing Change or Addition
Trelstar	triptorelin pamoate	Injectable; Intramuscular	Watson Labs	Manufacturing Change or Addition
Trelstar	triptorelin pamoate	Injectable; Intramuscular	Watson Labs	Manufacturing Change or Addition
Xeomin	incobotulinumtoxina	Injectable; Injection	Merz Pharms	Labeling Revision
Zenpep	pancrelipase (amylase;lipase;protease)	Capsule, Delayed Release; Oral	Aptalis Pharma Us	Labeling Revision
Zinecard	dexrazoxane hydrochloride	Injectable; Injection	Pharmacia and Upjohn	Manufacturing Change or Addition