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Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
November 2017

This report includes NDAs [including NDAs for new molecular entities (NMEs)] and BLAs (including new biological products) approved for the first time during the selected month. Original BLA/NDA approvals by CBER are not included in Drugs@FDA. This report does not include approved NDA or BLA supplements, approved ANDAs, or tentatively approved ANDAs/NDAs.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on April 25, 2024.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
11/02/2017 VYZULTA
NDA #207795		 LATANOPROSTENE BUNOD Type 1 - New Molecular Entity Standard BAUSCH AND LOMB
11/06/2017 BORTEZOMIB
NDA #205004		 BORTEZOMIB Type 5 - New Formulation or New Manufacturer Standard FRESENIUS KABI USA
11/08/2017 PREVYMIS
NDA #209939		 LETERMOVIR Type 1 - New Molecular Entity Priority MERCK SHARP DOHME
11/08/2017 PREVYMIS
NDA #209940		 LETERMOVIR Type 3 - New Dosage Form Priority MERCK SHARP DOHME
11/09/2017 CINVANTI
NDA #209296		 APREPITANT Type 3 - New Dosage Form Standard HERON THERAPS INC
11/13/2017 ABILIFY MYCITE KIT
NDA #207202		 ARIPIPRAZOLE Type 4 - New Combination Standard OTSUKA
11/14/2017 TEKTURNA
NDA #210709		 ALISKIREN HEMIFUMARATE Type 3 - New Dosage Form Priority NODEN PHARMA
11/14/2017 FASENRA
BLA #761070		 BENRALIZUMAB ASTRAZENECA AB
11/15/2017 MEPSEVII
BLA #761047		 VESTRONIDASE ALFA-VJBK ULTRAGENYX PHARM INC
11/16/2017 HEMLIBRA
BLA #761083		 EMICIZUMAB GENENTECH INC
11/21/2017 PALONOSETRON HYDROCHLORIDE
NDA #208109		 PALONOSETRON HYDROCHLORIDE Type 5 - New Formulation or New Manufacturer Standard FRESENIUS KABI USA
11/21/2017 JULUCA
NDA #210192		 DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE Type 4 - New Combination Priority VIIV HLTHCARE
11/28/2017 IMPOYZ
NDA #209483		 CLOBETASOL PROPIONATE Type 5 - New Formulation or New Manufacturer Standard PRIMUS PHARMS
11/28/2017 CLENPIQ
NDA #209589		 CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE Type 3 - New Dosage Form Standard FERRING PHARMS INC
11/30/2017 SUBLOCADE
NDA #209819		 BUPRENORPHINE Type 3 - New Dosage Form Priority INDIVIOR
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