CDER New: 7/21/2022

U.S. Food and Drug Administration sent this bulletin at 07/21/2022 06:48 AM EDT

What's New Related to Drugs

Updated Monday through Friday:

Recent New and Generic Drug Approvals

This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.

July 19, 2022

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Sensorcaine NDA #018304	Bupivacaine Hydrochloride	Injectable; Injection	SUPPL-50	Fresenius Kabi Usa	Labeling	Approved
Sensorcaine NDA #018304	Bupivacaine Hydrochloride; Epinephrine Bitartrate	Injectable; Injection	SUPPL-50	Fresenius Kabi Usa	Labeling	Approved
Lexette NDA #210566	Halobetasol Propionate	Aerosol, Foam; Topical	SUPPL-5	Mayne Pharma	Labeling	Approved
Aklief NDA #211527	Trifarotene	Cream; Topical	SUPPL-1	Galderma Labs Lp	Labeling	Approved
Aklief NDA #211527	Trifarotene	Cream; Topical	SUPPL-1	Galderma Labs Lp	Labeling	Approved
Aklief NDA #211527	Trifarotene	Cream; Topical	SUPPL-1	Galderma Labs Lp	Labeling	Approved
Pirfenidone ANDA #212722	Pirfenidone	Tablet; Oral	ORIG-1	Laurus		Approved
Pirfenidone ANDA #212724	Pirfenidone	Capsule; Oral	ORIG-1	Laurus		Approved
Pemetrexed NDA #214408	Pemetrexed	Solution; Intravenous	ORIG-1	Accord Hlthcare Inc	Type 3 - New Dosage Form	Approved
Phenoxybenzamine Hydrochloride ANDA #215042	Phenoxybenzamine Hydrochloride	Capsule; Oral	ORIG-1	Novitium Pharma		Approved
Norepinephrine Bitartrate ANDA #216341	Norepinephrine Bitartrate	Injectable; Injection	ORIG-1	Zydus Pharms		Approved

July 18, 2022

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Clolar NDA #021673	Clofarabine	Solution; Intravenous	SUPPL-27	Genzyme	Efficacy	Approved
Hydroxychloroquine Sulfate ANDA #040760	Hydroxychloroquine Sulfate	Tablet; Oral	SUPPL-9	Hikma Pharms	Labeling	Approved
Icosapent Ethyl ANDA #209499	Icosapent Ethyl	Capsule; Oral	ORIG-2	Dr Reddys		Tentative Approval
Vasopressin ANDA #211857	Vasopressin	Solution; Intravenous	ORIG-1	Amphastar Pharms Inc		Approved
Rozlytrek NDA #212725	Entrectinib	Capsule; Oral	SUPPL-6	Genentech Inc	Labeling	Approved
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid ANDA #212789	Citric Acid; Magnesium Oxide; Sodium Picosulfate	For Solution; Oral	ORIG-1	Hetero Labs Ltd V		Approved
Fenoprofen Calcium ANDA #214475	Fenoprofen Calcium	Capsule; Oral	ORIG-1	Rising		Approved
Opzelura NDA #215309	Ruxolitinib Phosphate	Cream; Topical	SUPPL-1	Incyte Corp	Efficacy	Approved
Pregabalin ANDA #216197	Pregabalin	Capsule; Oral	ORIG-1	Marksans Pharma		Approved
Hyrimoz BLA #761071	Adalimumab-Adaz	Injectable; Injection	SUPPL-10	Sandoz Inc	Efficacy	Approved
Hyrimoz BLA #761071	Adalimumab-Adaz	Injectable; Injection	SUPPL-12	Sandoz Inc	Efficacy	Approved

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