New and Generic Drug Approvals

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New and Generic Drug Approvals

April 12, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Colgate Total	sodium fluoride; triclosan	Paste; Dental	Colgate Palmolive	Manufacturing Change or Addition
Docetaxel	docetaxel	Injectable; Injection	Actavis Inc	Approval
Ortho Evra	ethinyl estradiol; norelgestromin	Film, Extended Release; Transdermal	Janssen Pharms	Manufacturing Change or Addition
Oxycodone and Acetaminophen	acetaminophen; oxycodone hydrochloride	Tablet; Oral	Actavis Elizabeth	Approval
Perjeta	pertuzumab	Vial; Single-Use	Genentech	Efficacy Supplement with Clinical Data to Support
Rocephin	ceftriaxone sodium	Injectable; Im-Iv	Hoffmann La Roche	Labeling Revision
Rocephin	ceftriaxone sodium	Injectable; Injection	Hoffmann La Roche	Labeling Revision
Rocephin Kit	ceftriaxone sodium; lidocaine	Injectable; Injection	Hoffmann La Roche	Labeling Revision
Sitavig	acyclovir	Tablet; Buccal	Bioalliance Pharma Sa	Approval
Vascepa	icosapent ethyl	Capsule; Oral	Amarin Pharma Inc	Manufacturing Change or Addition