CDER New July 12, 2017

What's New on the FDA Drugs Site

July 11, 2017

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Potassium Chloride Injection (Updated - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

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New and Generic Drug Approvals

July 11, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Enbrel BLA #103795	Etanercept	Syringe	SUPPL-5551	Immunex	Labeling	Approved
Enbrel BLA #103795	Etanercept	Vial; Subcutaneous	SUPPL-5551	Immunex	Labeling	Approved
Lupron NDA #019010	Leuprolide Acetate	Injectable; Injection	SUPPL-39	Abbvie Endocrine Inc	Labeling	Approved

July 10, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Avalide NDA #020758	Hydrochlorothiazide; Irbesartan	Tablet; Oral	SUPPL-72	Sanofi Aventis Us	Labeling	Approved
Children's Cetirizine Hydrochloride Allergy ANDA #090254	Cetirizine Hydrochloride	Syrup; Oral	SUPPL-20	Perrigo R and D	Labeling	Approved
Children's Cetirizine Hydrochloride Hives Relief ANDA #090254	Cetirizine Hydrochloride	Syrup; Oral	SUPPL-20	Perrigo R and D	Labeling	Approved
Duloxetine Hydrochloride ANDA #202045	Duloxetine Hydrochloride	Capsule, Delayed Rel Pellets; Oral	SUPPL-10	Apotex Inc	Labeling	Approved
Duloxetine Hydrochloride ANDA #202045	Duloxetine Hydrochloride	Capsule, Delayed Rel Pellets; Oral	SUPPL-2	Apotex Inc	Labeling	Approved
Duloxetine Hydrochloride ANDA #202045	Duloxetine Hydrochloride	Capsule, Delayed Rel Pellets; Oral	SUPPL-5	Apotex Inc	Labeling	Approved
Duloxetine Hydrochloride ANDA #202045	Duloxetine Hydrochloride	Capsule, Delayed Rel Pellets; Oral	SUPPL-6	Apotex Inc	Labeling	Approved
Duloxetine Hydrochloride ANDA #202045	Duloxetine Hydrochloride	Capsule, Delayed Rel Pellets; Oral	SUPPL-9	Apotex Inc	Labeling	Approved
Duloxetine Hydrochloride ANDA #202045	Duloxetine Hydrochloride	Capsule, Delayed Rel Pellets; Oral	SUPPL-10	Apotex Inc	Labeling	Approved
Octreotide Acetate (Preservative Free) ANDA #090834	Octreotide Acetate	Injectable; Injection	SUPPL-2	Sagent Pharms	Labeling	Approved
Octreotide Acetate ANDA #091041	Octreotide Acetate	Injectable; Injection	SUPPL-3	Sagent Pharms	Labeling	Approved
Plavix NDA #020839	Clopidogrel Bisulfate	Tablet; Oral	SUPPL-67	Sanofi Aventis Us	Labeling	Approved
Plavix NDA #020839	Clopidogrel Bisulfate	Tablet; Oral	SUPPL-67	Sanofi Aventis Us	Labeling	Approved
Xyzal NDA #022064	Levocetirizine Dihydrochloride	Tablet; Oral	SUPPL-33	Ucb Inc	Labeling	Approved
Xyzal NDA #022157	Levocetirizine Dihydrochloride	Solution; Oral	SUPPL-16	Ucb Inc	Labeling	Approved

 

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— Wednesday, July 12, 2017 — Add Comment