CDER New September 8, 2017

What's New on the FDA Drugs Site

September 7, 2017

• FDA Drug Shortages
  • Technetium Tc99m Succimer Injection (DMSA) (Updated - Currently in Shortage)
• New Spotlight on CDER Science: FDA Researchers Explore Fundamental Chemical Reaction that Could Threaten the Quality of Therapeutic Protein Products
• Genentech Issues Voluntary Nationwide Recall of Three Lots of Activase (Alteplase)-100 mg Due to Lack of Sterility Assurance of the Sterile Water for Injection

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New and Generic Drug Approvals

September 7, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Abstral NDA #022510	Fentanyl Citrate	Tablet; Sublingual	SUPPL-17	Sentynl Theraps Inc	REMS	Approved
Actiq NDA #020747	Fentanyl Citrate	Troche/Lozenge; Transmucosal	SUPPL-47	Cephalon	REMS	Approved
Fentanyl Citrate ANDA #077312	Fentanyl Citrate	Troche/Lozenge; Transmucosal	SUPPL-9	Par Pharm	REMS	Approved
Fentanyl Citrate ANDA #078907	Fentanyl Citrate	Troche/Lozenge; Transmucosal	SUPPL-16	Mallinckrodt	REMS	Approved
Fentanyl Citrate ANDA #079075	Fentanyl Citrate	Tablet; Buccal, Sublingual	SUPPL-13	Watson Labs	REMS	Approved
Fentora NDA #021947	Fentanyl Citrate	Tablet; Buccal, Sublingual	SUPPL-27	Cephalon	REMS	Approved
Lazanda NDA #022569	Fentanyl Citrate	Spray, Metered; Nasal	SUPPL-26	Depomed Inc	REMS	Approved
Onsolis NDA #022266	Fentanyl Citrate	Film; Buccal	SUPPL-19	Bdsi	REMS	Approved
Subsys NDA #202788	Fentanyl	Spray; Sublingual	SUPPL-18	Insys Dev Co Inc	REMS	Approved

September 6, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Ameluz NDA #208081	Aminolevulinic Acid Hydrochloride	Gel; Topical	SUPPL-2	Biofrontera	Labeling	Approved
Avagard NDA #021074	Alcohol; Chlorhexidine Gluconate	Solution; Topical	SUPPL-12	3m	Labeling	Approved
Chlorhexidine Gluconate NDA #021669	Chlorhexidine Gluconate	Cloth; Topical	SUPPL-23	Sage Prods	Labeling	Approved
Doxycycline Hyclate ANDA #207558	Doxycycline Hyclate	Tablet; Oral	ORIG-1	Novel Labs Inc		Approved
Gleevec NDA #021588	Imatinib Mesylate	Tablet; Oral	SUPPL-51	Novartis	Labeling	Approved
Guaifenesin ANDA #209215	Guaifenesin	Tablet, Extended Release; Oral	ORIG-1	Guardian Pharms		Approved
Opdivo BLA #125554	Nivolumab	Injectable; Injection	SUPPL-40	Bristol Myers Squibb	Labeling	Approved
Oxaliplatin ANDA #205529	Oxaliplatin	Injectable; Iv (Infusion)	ORIG-1	Sanja Pharms Co		Approved
Oxycodone Hydrochloride ANDA #209897	Oxycodone Hydrochloride	Solution; Oral	ORIG-1	Wes Pharma Inc		Approved

 

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— Friday, September 8, 2017 — 2 Comments