CDER New July 19, 2017

What's New on the FDA Drugs Site

July 18, 2017

• Current Biomarker Qualification Submissions (updated)
• Development of New Tuberculosis Drug Regimens-Scientific and Clinical Design Considerations (updated)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA approves Nerlynx (neratinib), a new treatment to reduce the risk of breast cancer returning
• FDA approves Vosevi for Hepatitis C
• FDA Drug Shortages
  • Dexrazoxane Injection (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 18, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Cefuroxime Axetil ANDA #065126	Cefuroxime Axetil	Tablet; Oral	SUPPL-2	Sandoz	Labeling	Approved
Cefuroxime Axetil ANDA #065166	Cefuroxime Axetil	Tablet; Oral	SUPPL-2	Wockhardt	Labeling	Approved
Cefuroxime Axetil ANDA #065308	Cefuroxime Axetil	Tablet; Oral	SUPPL-11	Aurobindo Pharma Ltd	Labeling	Approved

July 17, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Amifostine ANDA #204363	Amifostine	Injectable; Injection	ORIG-1	Mylan Labs Ltd		Approved
Amlodipine Besylate and Olmesartan Medoxomil ANDA #207073	Amlodipine Besylate; Olmesartan Medoxomil	Tablet; Oral	ORIG-1	Alembic Pharms Ltd		Approved
Choline C-11 ANDA #205690	Choline C-11	Injectable; Intravenous	SUPPL-2	Univ Tx Md Anderson	Manufacturing (CMC)	Approved
Choline C-11 ANDA #205690	Choline C-11	Injectable; Intravenous	SUPPL-2	Univ Tx Md Anderson	Manufacturing (CMC)	Approved
Dexamethasone ANDA #201270	Dexamethasone	Tablet; Oral	ORIG-1	Larken Labs Inc		Approved
Fluocinolone Acetonide ANDA #202849	Fluocinolone Acetonide	Oil/Drops; Otic	ORIG-1	Perrigo Israel		Approved
Lidocaine ANDA #205318	Lidocaine	Ointment; Topical	SUPPL-1	Teligent Pharma Inc	Manufacturing (CMC)	Approved
Lidocaine ANDA #205318	Lidocaine	Ointment; Topical	SUPPL-1	Teligent Pharma Inc	Manufacturing (CMC)	Approved
Midozalam Hydrochloride ANDA #090316	Midazolam Hydrochloride	Injectable; Injection	SUPPL-9	Sagent Strides	Labeling	Approved
Nerlynx NDA #208051	Neratinib Maleate	Tablet; Oral	ORIG-1	Puma Biotech Inc	Type 1 - New Molecular Entity	Approved
Sevelamer Carbonate ANDA #207179	Sevelamer Carbonate	Tablet; Oral	ORIG-1	Aurobindo Pharma Ltd		Approved
Tranexamic Acid ANDA #205228	Tranexamic Acid	Injectable; Injection	ORIG-1	Zydus Pharms Usa Inc		Approved

 

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— Wednesday, July 19, 2017 — Add Comment