Original New Drug Application Approvals by US FDA (16-30 Apr 2023)
08 May 2023
New drug applications approved by US FDA as of 16-30 April 2023 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.
EPINEPHRINE IN 0.9% SODIUM CHLORIDE
EPINEPHRINE IN 0.9% SODIUM CHLORIDE
- Active Ingredient(s): Epinephrine
- Strength: 2MG/250ML (8MCG/ML), 4MG/250ML (16MCG/ML), 5MG/250ML (20MCG/ML), 8MG/250ML (32MCG/ML), 10MG/250ML (40MCG/ML)
- Dosage Form(s) / Route(s): Solution;intravenous
- Company: Par Sterile Products
- Approval Date: 21 April 2023
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
- Approved Label: 21 April (PDF)
- Active Ingredient(s): Tofersen
- Strength: 100MG/15ML(6.7MG/ML)
- Dosage Form(s) / Route(s): Injectable;injection
- Company: Biogen Idec Inc
- Approval Date: 25 April 2023
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain observed in patients treated with QALSODY. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).
- Approved Label: 25 April (PDF)
- Active Ingredient(s): Niraparib
- Strength: 100MG
- Dosage Form(s) / Route(s): Tablet;oral
- Company: Glaxosmithkline Llc
- Approval Date: 26 April 2023
- Submission Classification: Type 3 - New Dosage Form
- Indication(s): Indicated:
- for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
- for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for ZEJULA.
- Approved Label: 26 April (PDF)
- Active Ingredient(s): Elexacaftor;tezacaftor;ivacaftor;ivacaftor
- Strength: 50MG;25MG;37.5MG;75MG
- Dosage Form(s) / Route(s): Granules;oral
- Company: Vertex Pharms Inc
- Approval Date: 26 April 2023
- Submission Classification: Type 3 - New Dosage Form
- Indication(s): Indicated for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one F508del mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data. If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one F508del mutation or a mutation that is responsive based on in vitro data.
- Approved Label: 26 April (PDF)
- Active Ingredient(s): Aripiprazole
- Strength: 720MG/2.4ML, 960MG/3.2ML
- Dosage Form(s) / Route(s): For Suspension, Extended Release; Injectable
- Company: Otsuka Pharm Co Ltd
- Approval Date: 27 April 2023
- Submission Classification: Type 3 - New Dosage Form
- Indication(s): Indicated:
- for the treatment of schizophrenia in adults
- as maintenance monotherapy treatment of bipolar I disorder in adults
- Approved Label: 27 April (PDF)
- Active Ingredient(s): RISPERIDONE
- Strength: NA
- Dosage Form(s) / Route(s): Suspension, Extended Release;subcutaneous
- Company: Teva Neuroscience Inc
- Approval Date: 28 April 2023
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated for the treatment of schizophrenia in adults.
- Approved Label: 28 April (PDF)
- Active Ingredient(s): Sildenafil
- Strength: 10MG/ML
- Dosage Form(s) / Route(s): For Suspension; Oral
- Company: Cmp Dev Llc
- Approval Date: 28 April 2023
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening.
- Approved Label: 28 April (PDF)
- Active Ingredient(s): Budesonide And Formoterol Fumarate
- Strength: 160MCG/4.8MCG
- Dosage Form(s) / Route(s): Aerosol, Metered;inhalation
- Company: Astrazeneca Pharms Lp
- Approval Date: 28 April 2023
- Submission Classification: Efficacy
- Indication(s): Indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Limitations of Use: Not indicated for the relief of acute bronchospasm or for the treatment of asthma.
- Approved Label: 28 April (PDF)
