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CDER New November 13, 2013

What's New on the FDA Drugs Site

November 13, 2013

FDA Drug Safety Communication: FDA requests label changes and single-use packaging for some over-the-counter topical antiseptic products to decrease risk of infection
Drug Firm Annual Registration Status (updated)
Drug Firm Annual Registration Status Download File (updated)
Drugs@FDA Data Files (updated)
FDA approves Imbruvica (ibrutinib) for rare blood cancer
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (updated)
National Drug Code Directory
Pediatric Statistics:
- Pediatric Exclusivity Statistics (updated)
- Written Requests Issued (updated)
Postmarket Requirements and Commitments (updated)
Spanish FDA Drug Safety Communication: Recomendaciones actualizadas para disminuir el sangrado de la columna vertebral y parálisis en pacientes que usan heparinas de bajo peso molecular

New and Generic Drug Approvals

November 12, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Actoplus Met XR	metformin hydrochloride; pioglitazone hydrochloride	Tablet, Extended Release;Oral	Takeda Pharms USA	Labeling Revision
Actos	pioglitazone hydrochloride	Tablet;Oral	Takeda Pharms USA	Labeling Revision
Duetact	glimepiride; pioglitazone hydrochloride	Tablet;Oral	Takeda Pharms USA	Labeling Revision
Methylphenidate Hydrochloride	methylphenidate hydrochloride	Solution;Oral	Caraco	Approval
Mozobil	plerixafor	Solution;Subcutaneous	Genzyme	Manufacturing Change or Addition
Octreotide Acetate	octreotide acetate	Injectable;Injection	Sagent Pharms	Approval
Octreotide Acetate (Preservative Free)	octreotide acetate	Injectable;Injection	Sagent Pharms	Approval
Valstar Preservative Free	valrubicin	Solution;Intravesical	Endo Pharm	Manufacturing Change or Addition

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