New and Generic Drug Approvals
August 20, 2015
|
Drug Name
|
Active Ingredient
|
Dosage Form/Route
|
Sponsor
|
Submission Type
|
|
Ramelteon
|
ramelteon
|
Tablet;Oral
|
Actavis Labs Fl Inc
|
Approval
|
August 19, 2015
|
Drug Name
|
Active Ingredient
|
Dosage Form/Route
|
Sponsor
|
Submission Type
|
|
Cabazitaxel Injection
|
cabazitaxel
|
Injectable;Injection
|
Actavis Llc
|
Tentative Approval
|
|
Cisplatin
|
cisplatin
|
Injectable;Injection
|
Accord Hlthcare
|
Approval
|
|
Ibandronate Sodium
|
ibandronate sodium
|
Injectable;Intravenous
|
Aurobindo Pharma Ltd
|
Approval
|
|
Implanon
|
etonogestrel
|
Implant;Implantation
|
Organon Usa Inc
|
Labeling Revision
|
|
Kinevac
|
sincalide
|
Injectable;Injection
|
Bracco
|
Manufacturing Change or Addition
|
|
Nexplanon
|
etonogestrel
|
Implant;Implantation
|
Organon Usa Inc
|
Labeling Revision
|
|
Northera
|
droxidopa
|
Capsule;Oral
|
Lundbeck Na Ltd
|
Manufacturing Change or Addition
|
|
Omeprazole
|
omeprazole
|
Capsule, Delayed Rel Pellets;Oral
|
Aurobindo Pharma Usa
|
Approval
|
|
Oxistat
|
oxiconazole nitrate
|
Lotion;Topical
|
Fougera Pharms
|
Manufacturing Change or Addition
|
|
Potassium Chloride For Oral Solution
|
potassium chloride
|
Solution;Oral
|
Pharma Research Software Solution Llc
|
Approval
|
|
Sovaldi
|
sofosbuvir
|
Tablet;Oral
|
Gilead Sciences Inc
|
Labeling Revision
|
August 18, 2015