CDER New March 10, 2017

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What’s New on the FDA Drugs Site

March 9, 2017


New and Generic Drug Approvals

March 8, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Exparel
NDA #022496
Bupivacaine Injectable, Liposomal; Injection SUPPL-23 Pacira Pharms Inc LABELING Approved
Finasteride
ANDA #204304
Finasteride Tablet; Oral SUPPL-1 Alkem Labs Ltd MANUF (CMC) Approved
Iluvien
NDA #201923
Fluocinolone Acetonide Implant; Intravitreal SUPPL-2 Alimera Sciences Inc LABELING Approved
Linzess
NDA #202811
Linaclotide Capsule; Oral SUPPL-13 Forest Labs Llc LABELING Approved
Nipride Rtu (Sodium Nitroprusside)
NDA #209387
Sodium Nitroprusside;Sodium Chloride Injectable; Injection ORIG-1 Exela Pharma Science TYPE 5 Approved
Pantoprazole Sodium
ANDA #204400
Pantoprazole Sodium Injectable; Iv (Infusion) ORIG-1 Hospira Inc   Tentative Approval
Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
ANDA #202060
Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride For Solution; Oral ORIG-1 Breckenridge Pharms   Approved
Symlin
NDA #021332
Pramlintide Acetate Injectable; Subcutaneous SUPPL-26 Astrazeneca Ab REMS Approved
Zofran
NDA #020007
Ondansetron Hydrochloride Injectable; Injection SUPPL-47 Novartis Pharms Corp LABELING Approved
Zofran Preservative Free
NDA #020007
Ondansetron Hydrochloride Injectable; Injection SUPPL-47 Novartis Pharms Corp LABELING Approved

 

 

 


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