CDER New: 3/28/2023
US FDA sent this email to their subscribers on March 28, 2023.
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. March 27, 2023March 24, 2023 |
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ADMINISTRATION RN LR LU
What's New Related to Drugs
Updated Monday through Friday:
* Drug Firm Annual Registration Status
* Drug Firm Annual Registration Status Download File
* National Drug Code Directory
* NDC Unfinished Drugs Excluded Database File
* NDC Database Excluded Packages and Products
* Wholesale Distributor and Third-Party Logistics Providers Reporting
March 24, 2023
* FDA approves first treatment for activated phosphoinositide 3-kinase delta syndrome
* FDA Drug Shortages
* Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
* Hydrocortisone Sodium Succinate Injection (New - Currently in Shortage)
* Ketamine Injection (Updated - Currently in Shortage)
* Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
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.
MARCH 27, 2023
Drug Name and
Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Veltassa
NDA #205739 Patiromer Sorbitex Calcium Powder; Oral SUPPL-37 Vifor Pharma Labeling Approved Narcan
NDA #208411 Naloxone Hydrochloride Spray, Metered; Nasal SUPPL-7 Emergent Labeling Approved Narcan
NDA #208411 Naloxone Hydrochloride Spray, Metered; Nasal SUPPL-7 Emergent Labeling Approved
MARCH 24, 2023
Drug Name and
Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Thalomid
NDA #020785 Thalidomide Capsule; Oral SUPPL-71 Celgene REMS Approved Revlimid
NDA #021880 Lenalidomide Capsule; Oral SUPPL-67 Celgene REMS Approved Absorica
NDA #021951 Isotretinoin Capsule; Oral SUPPL-22 Sun Pharm Inds Inc REMS Approved Amnesteem
ANDA #075945 Isotretinoin Capsule; Oral SUPPL-46 Mylan Pharms Inc REMS Approved Claravis
ANDA #076135 Isotretinoin Capsule; Oral SUPPL-60 Teva Pharms Usa REMS Approved Claravis
ANDA #076356 Isotretinoin Capsule; Oral SUPPL-55 Teva Pharms Usa REMS Approved Lenalidomide
ANDA #201452 Lenalidomide Capsule; Oral SUPPL-6 Arrow Intl REMS Approved Zenatane
ANDA #202099 Isotretinoin Capsule; Oral SUPPL-33 Dr Reddys Labs Ltd REMS Approved Fenofibrate
ANDA #202856 Fenofibrate Tablet; Oral SUPPL-10 Mylan Pharms Inc Labeling Approved Pomalyst
NDA #204026 Pomalidomide Capsule; Oral SUPPL-31 Bristol REMS Approved Fetzima
NDA #204168 Levomilnacipran Hydrochloride Capsule, Extended Release; Oral SUPPL-10 Abbvie Efficacy Approved Isotretinoin
ANDA #205063 Isotretinoin Capsule; Oral SUPPL-5 Actavis Labs Fl REMS Approved Isotretinoin
ANDA #207792 Isotretinoin Capsule; Oral SUPPL-24 Amneal Pharms Ny REMS Approved Pregabalin
ANDA #207883 Pregabalin Capsule; Oral SUPPL-1 Prinston Inc Labeling Approved Pregabalin
ANDA #207883 Pregabalin Capsule; Oral SUPPL-1 Prinston Inc Labeling Approved Pregabalin
ANDA #207883 Pregabalin Capsule; Oral SUPPL-1 Prinston Inc Labeling Approved Her Style
ANDA #207976 Levonorgestrel Tablet; Oral SUPPL-6 Novast Labs Labeling Approved Lenalidomide
ANDA #209348 Lenalidomide Capsule; Oral SUPPL-4 Dr Reddys REMS Approved Lenalidomide
ANDA #210154 Lenalidomide Capsule; Oral SUPPL-2 Zydus Pharms REMS Approved Lenalidomide
ANDA #210435 Lenalidomide Capsule; Oral SUPPL-2 Cipla REMS Approved Lenalidomide
ANDA #210480 Lenalidomide Capsule; Oral SUPPL-3 Lotus Pharm Co Ltd REMS Approved Lenalidomide
ANDA #211022 Lenalidomide Capsule; Oral SUPPL-2 Apotex REMS Approved Lenalidomide
ANDA #211846 Lenalidomide Capsule; Oral SUPPL-1 Sun Pharm REMS Approved Loratadine
ANDA #211900 Loratadine Capsule; Oral ORIG-1 Aurobindo Pharma Approved Absorica Ld
NDA #211913 Isotretinoin Capsule; Oral SUPPL-10 Sun Pharm REMS Approved Isotretinoin
ANDA #212333 Isotretinoin Capsule; Oral SUPPL-8 Upsher Smith Labs REMS Approved Lenalidomide
ANDA #213405 Lenalidomide Capsule; Oral SUPPL-1 Torrent REMS Approved Evrysdi
NDA #213535 Risdiplam For Solution; Oral SUPPL-8 Genentech Inc Manufacturing (CMC) Approved Isotretinoin
ANDA #213571 Isotretinoin Capsule; Oral SUPPL-7 Upsher Smith Labs REMS Approved Tabrecta
NDA #213591 Capmatinib Hydrochloride Tablet; Oral SUPPL-7 Novartis Pharm Labeling Approved Tabrecta
NDA #213591 Capmatinib Hydrochloride Tablet; Oral SUPPL-7 Novartis Pharm Labeling Approved Lenalidomide
ANDA #213885 Lenalidomide Capsule; Oral SUPPL-1 Eugia Pharma REMS Approved Lenalidomide
ANDA #213912 Lenalidomide Capsule; Oral SUPPL-2 Mylan REMS Approved Pregabalin
ANDA #214322 Pregabalin Capsule; Oral SUPPL-3 Changzhou Pharm Labeling Approved Aminocaproic Acid
ANDA #214458 Aminocaproic Acid Solution; Oral ORIG-1 Taro Pharms Approved Lenalidomide
ANDA #214618 Lenalidomide Capsule; Oral SUPPL-1 Cipla REMS Approved Quviviq
NDA #214985 Daridorexant Hydrochloride Tablet; Oral SUPPL-4 Idorsia Labeling Approved Quviviq
NDA #214985 Daridorexant Hydrochloride Tablet; Oral SUPPL-4 Idorsia Labeling Approved Carbamazepine
ANDA #216193 Carbamazepine Tablet, Extended Release; Oral ORIG-1 Ajanta Pharma Ltd Approved Dicyclomine Hydrochloride
ANDA #216639 Dicyclomine Hydrochloride Capsule; Oral ORIG-1 Corepharma Approved Levothyroxine Sodium
ANDA #217066 Levothyroxine Sodium Powder; Intravenous ORIG-1 Zydus Pharms Approved Joenja
NDA #217759 Leniolisib Phosphate Tablet; Oral ORIG-1 Pharming Technologies Bv Type 1 - New Molecular Entity Approved
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