CDER New July 26, 2017

What's New on the FDA Drugs Site

July 25, 2017

• Biosimilar User Fee Act (BsUFA) (updated)
• FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) (Update) 
• Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.): Two approvals for ALK-positive non-small cell lung cancer
• Consumer Antiseptic Wash Final Rule Questions and Answers Guidance for Industry (PDF - 91KB)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Approval Package:  
  • Baxdela (delafloxacin) Tablets and Injection
  • Bevyxxa Capsule
• Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance Guidance for Industry (PDF - 132KB)
• National Drug Code Directory
• Prescription Drug User Fee Act (PDUFA) (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

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New and Generic Drug Approvals

July 25, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Invokamet NDA #204353	Canagliflozin; Metformin Hydrochloride	Tablet; Oral	SUPPL-23	Janssen Pharms	Labeling	Approved
Invokamet Xr NDA #205879	Canagliflozin; Metformin Hydrochloride	Tablet, Extended Release; Oral	SUPPL-5	Janssen Pharms	Labeling	Approved
Invokana NDA #204042	Canagliflozin	Tablet; Oral	SUPPL-26	Janssen Pharms	Labeling	Approved

July 24, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Clindamycin Hydrochloride ANDA #065242	Clindamycin Hydrochloride	Capsule; Oral	SUPPL-21	Lannett	Labeling	Approved
Clindamycin Hydrochloride ANDA #065243	Clindamycin Hydrochloride	Capsule; Oral	SUPPL-17	Lannett	Labeling	Approved
Desonide ANDA #209729	Desonide	Cream; Topical	ORIG-1	Glenmark Pharms		Approved
Elifemme ANDA #202507	Ethinyl Estradiol; Levonorgestrel	Tablet; Oral-28	SUPPL-1	Labs Leon Farma	Labeling	Approved
Levora 0.15/30-28 ANDA #073594	Ethinyl Estradiol; Levonorgestrel	Tablet; Oral-28	SUPPL-25	Mayne Pharma	Labeling	Approved
Lovastatin ANDA #075935	Lovastatin	Tablet; Oral	SUPPL-6	Mylan	Labeling	Approved
Xtandi NDA #203415	Enzalutamide	Capsule; Oral	SUPPL-11	Astellas	Efficacy	Approved

 

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— Wednesday, July 26, 2017 — Add Comment