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What's New on the FDA Drugs Site

May 12, 2017

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Trials Snapshots: IMFINZI
• National Drug Code Directory
• Orange Book (updated)
  • Orange Book Current Cumulative Supplement (PDF - 874KB)
  • April 2017: Additions and Deletions to the Drug Product List (PDF - 232KB)
  • Orange Book Data Files (compressed)  (ZIP - 647KB)
  • Reference Listed Drugs by ANDA Reference Standard List (PDF - 86KB)
• Wholesale Distributor and Third-Party Logistics Providers Reporting(updated)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act of 2012 (FDASIA) (updated)

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New and Generic Drug Approvals

May 12, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Dyanavel Xr  NDA #208147	Amphetamine	Suspension, Extended Release; Oral	SUPPL-3	Tris Pharma Inc	Manufacturing (CMC)	Approved
Topamax  NDA #020505	Topiramate	Tablet; Oral	SUPPL-57	Janssen Pharms	Labeling	Approved

May 11, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Acitretin  ANDA #202552	Acitretin	Capsule; Oral	SUPPL-2	Impax Labs Inc	Labeling	Approved
Acitretin  ANDA #202552	Acitretin	Capsule; Oral	SUPPL-2	Impax Labs Inc	Labeling	Approved
Acitretin  ANDA #202552	Acitretin	Capsule; Oral	SUPPL-2	Impax Labs Inc	Labeling	Approved
Carisoprodol  ANDA #207237	Carisoprodol	Tablet; Oral	ORIG-1	Nostrum Labs Inc		Approved
Empliciti  BLA #761035	Elotuzumab	Injectable; Injection	SUPPL-5	Bristol Myers Squibb	Efficacy	Approved
Methylphenidate Hydrochloride  ANDA #206932	Methylphenidate Hydrochloride	Tablet; Oral	ORIG-1	Abhai Inc		Approved

Allergy Alert Issued by Arabella Station Whole Foods Market for Undeclared Walnuts in Oatmeal Chocolate Chip Cookies

05/15/2017 09:09 AM EDT

The Arabella Station Whole Foods Market store, located at 5600 Magazine Street in New Orleans, is voluntarily recalling packaged oatmeal chocolate chip cookies because the product contained tree nut allergens (walnuts) that were not listed on the product label. People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reaction if they consume these products.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.