CDER New August 27, 2013

What's New on the FDA Drugs Site

August 27, 2013

Current Drug Shortages Index (updated)

• Resolved Drug Shortage: Methoxsalen 1% Topical Lotion (Oxsoralen)

Drug Firm Annual Registration Status (updated)

Drug Firm Annual Registration Status Download File (updated) 

MedWatch Safety Alert: Compounded Sterile Preparations By Park Pharmacy & Compounding Center: Recall - Lack of Sterility Assurance  

National Drug Code Directory  

Orange Book

• Additions/Deletions for Prescription and OTC Drug Product Lists
• Orange Book Current Cumulative Supplement (PDF - 1011KB)
• Orange Book Data Files (compressed) (ZIP - 597KB)
• Orange Book Search

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New and Generic Drug Approvals

August 26, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Betadine	povidone-iodine	Solution/Drops; Ophthalmic	Alcon Pharms Ltd	Manufacturing Change or Addition
Ethyol	amifostine	Injectable; Injection	Medimmune	Manufacturing Change or Addition
Invega Sustenna	paliperidone palmitate	Suspension, Extended Release; Intramuscular	Janssen Pharms	Manufacturing Change or Addition
Larin Fe 1/20	ethinyl estradiol; norethindrone acetate	Tablet; Oral-28	Novast Labs Ltd	Approval
Optimark	gadoversetamide	Injectable; Injection	Mallinckrodt	Labeling Revision
Optimark	gadoversetamide	Injectable; Injection	Mallinckrodt	Labeling Revision
Optimark In Plastic Container	gadoversetamide	Injectable; Injection	Mallinckrodt	Labeling Revision

 

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