Original New Drug Application Approvals by US FDA (16 - 28 February 2022)

New drug applications approved by US FDA as of 16-28 February 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.

PYRUKYND

• Active Ingredient(s): Mitapivat Sulfate
• Strength: EQ 5MG BASE; EQ 20MG BASE; EQ 50MG BASE
• Dosage Form(s) / Route(s): Tablet; Oral
• Company:  Agios Pharms Inc
• Approval Date: 17 February 2022
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency
• Approved Label: 17 February 2022 (PDF)

NEPHROSCAN

• Active Ingredient(s): Technetium Tc-99m Succimer Kit
• Strength: N/A
• Dosage Form(s) / Route(s): Powder; Intravenous
• Company:  Theragnostics Inc
• Approval Date: 18 February 2022
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for use as an aid in the scintigraphic evaluation of renal parenchymal disorders in adults and pediatric patients including term neonates.
• Approved Label: 18 February 2022 (PDF)

NORLIQVA

• Active Ingredient(s): Amlodipine
• Strength: 1MG/1ML
• Dosage Form(s) / Route(s): Solution; Oral
• Company:  CMP DEV LLC
• Approval Date: 24 February 2022
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for
  • Hypertension
    • The treatment of hypertension in adults and children 6 years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
  • Coronary Artery Disease
    • Chronic Stable Angina 
    • Vasospastic Angina (Prinzmetal's or Variant Angina)
    •  Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction <40%
• Approved Label: 24 February 2022 (PDF)

ACUVUE THERAVISION WITH KETOTIFEN

• Active Ingredient(s): Etafilcon A Lens With Ketotifen
• Strength: 19MCG PER LENS
• Dosage Form(s) / Route(s): Solution; Optical
• Company:  Johnson And Johnson Vision Care, Inc
• Approval Date: 25 February 2022
• Submission Classification: Type 3 - New Dosage Form and Type 4 - New Combination
• Indication(s): Indicated for the prevention ocular itch due to allergic conjunctivitis and correction of refractive ametropia (myopia and hyperopia) in aphakic and/or phakic patients who do not have red eye(s), are suitable for contact lens wear and do not have more than 1 D of astigmatism. 
• Approved Label: 25 February 2022 (PDF)

RELEUKO

• Active Ingredient(s): Filgrastim-ayow
• Strength: 300MCG/ML
• Dosage Form(s) / Route(s): Injectable; Injection
• Company: Kashiv Biosciences Llc
• Approval Date: 25 February 2022
• Submission Classification:Not available
• Indication(s): Indicated to
  • Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti- cancer drugs associated with a significant incidence of severe neutropenia with fever.
  • Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).
  • Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).
  • Reduce the incidence and duration of sequelae of severe neutropenia‚ (e.g., fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.
• Approved Label: 25 February 2022 (PDF)

VONJO

• Active Ingredient(s): Pacritinib
• Strength: 100MG
• Dosage Form(s) / Route(s): Capsule; Oral
• Company: Cti Biopharma Corp
• Approval Date: 28 February 2022
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Not available
• Approved Label: Not available

NALOXONE HYDROCHLORIDE

• Active Ingredient(s): Naloxone Hydrochloride
• Strength: 10MG
• Dosage Form(s) / Route(s): Injectable; Injection
• Company: Kaleo Inc
• Approval Date: 28 February 2022
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s):  indicated for use by military personnel and chemical incident responders for:
  • Emergency treatment of patients 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected.
  • Temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues.
• Approved Label: 28 February 2022 (PDF)

ASPRUZYO SPRINKLE

• Active Ingredient(s): Ranolazine
• Strength: 500MG; 1000MG
• Dosage Form(s) / Route(s): Granule; Extended Release
• Company:  Sun Pharma Global
• Approval Date: 28 February 2022
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency. 
• Approved Label: 28 February 2022 (PDF)