Original New Drug Application Approvals by US FDA (16 - 31 March 2022)
05 Apr 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
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 Label: 18 March 2022 (PDF)
- 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 Label: 18 March 2022 (PDF)
- 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 Label: 22 March 2022 (PDF)
- 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 Label: 22 March 2022 (PDF)
- 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 Label: 23 March 2022 (PDF)
- 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
- 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
- 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)