Original New Drug Application Approvals by US FDA (16 - 31 March 2022)

05 Apr 2022
Original New Drug Application Approvals by US FDA (16 - 31 March 2022)
New drug applications approved by US FDA as of 16-31 March 2022 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

ZTALMY
  • Active Ingredient(s): Ganaxolone
  • Strength: 50MG/ML
  • Dosage Form(s) / Route(s): Suspension; Oral
  • Company: Marinus
  • Approval Date: 18 March 2022
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older. 
  • Approved Label18 March 2022 (PDF)
OPDUALAG
  • Active Ingredient(s): Nivolumab; Elatlimab-rmbw
  • Strength: 240MG;80MG
  • Dosage Form(s) / Route(s): Solution; Intravenous
  • Company: Bristol Myers Squibb
  • Approval Date: 18 March 2022
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
  • Approved Label18 March 2022 (PDF)
HYFTOR
  • Active Ingredient(s): Sirolimus
  • Strength: 0.2%
  • Dosage Form(s) / Route(s): Gel; Topical
  • Company: Nobelpharma Co., Ltd.
  • Approval Date: 22 March 2022
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older.
  • Approved Label22 March 2022 (PDF)
XELSTRYM
  • Active Ingredient(s): Dextroamphetamine
  • Strength: 4.5MG/9HR; 9MG/9HR; 13.5MG/9HR; 18.5MG/9HR
  • Dosage Form(s) / Route(s): System; Transdermal
  • Company: Oven Pharms Inc
  • Approval Date: 22 March 2022
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.
  • Approved Label22 March 2022 (PDF)
PLUVICTO
  • Active Ingredient(s): Lutetium (177lu) Vipivotide Tetraxetan
  • Strength: 1000 MBQ/ML (27MCI/ML)
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Advanced Accelerator Applications Usa Inc A Novart
  • Approval Date: 23 March 2022
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. 
  • Approved Label23 March 2022 (PDF)
LOCAMETZ KIT
  • Active Ingredient(s): Gallium Ga 68 Gozetotide
  • Strength: 37MCI/VIAL
  • Dosage Form(s) / Route(s): Powder; Intravenous
  • Company: Advanced Accelerator Applications Usa Inc A Novart
  • Approval Date: 23 March 2022
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Not available
  • Approved Label: Not available
DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE
  • Active Ingredient(s): Dolutegravir Lamivudine Tenofovir Alafenamide
  • Strength: EQ 50MG BASE; 300MG; 25MG
  • Dosage Form(s) / Route(s): Tablet, For Suspension; Oral
  • Company: Cipla Usa Inc.
  • Approval Date: 30 March 2022
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Not available
  • Approved Label: Not available
TRIUMEQ PD
  • Active Ingredient(s): Abacavir Dolutegravir Lamivudine
  • Strength: EQ 60MG BASE; 5MG; 30MG
  • Dosage Form(s) / Route(s): Tablet, For Suspension; Oral
  • Company: Viiv Hlthcare
  • Approval Date: 30 March 2022
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s):  Indicated for the treatment of HIV-1 infection in adults and in pediatric patients weighing at least 10 kg
  • Approved Label: 30 March 2022 (PDF)
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