Original New Drug Application Approvals by US FDA (16-31 July 2025)

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Original New Drug Application Approvals by US FDA (16-31 July 2025)
New drug applications approved by US FDA as of 16-31 July 2025 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.

FAMOTIDINE
  • Active Ingredient(s): Famotidine
  • Strength: 20MG/5ML (4MG/ML); 40MG/10ML (4MG/ML); 200MG/50ML (4MG/ML)
  • Dosage Form(s) / Route(s): Solution;intravenous
  • Company: Sagent
  • Approval Date: 16 July 2025
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated:
    • In hospitalized adults, or as an alternative to oral famotidine in adults, for the treatment of:
    • active duodenal ulcer (DU).
    • active gastric ulcer (GU).
    • symptomatic nonerosive gastroesophageal reflux disease (GERD).
    • erosive esophagitis due to GERD, diagnosed by endoscopy.
    • treatment of pathological hypersecretory conditions (e.g., ZollingerEllison syndrome, multiple endocrine neoplasias).
    • reduction of the risk of DU recurrence.
    In hospitalized pediatric patients 1 year of age and older, or as an alternative to oral famotidine in pediatric patients 1 year of age and older, for the treatment of:
    • peptic ulcer disease.
  • Approved Label:  16 July 2025 (PDF)
ANZUPGO
  • Active Ingredient(s): Delgocitinib
  • Strength: 2%
  • Dosage Form(s) / Route(s): Cream;topical
  • Company: Leo Pharma As
  • Approval Date: 23 July 2025
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable.
    • Limitations of Use: Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.
  • Approved Label:  23 July 2025 (PDF)
VOSTALLY
  • Active Ingredient(s): Ramipril
  • Strength: 1MG/ML
  • Dosage Form(s) / Route(s): Solution;oral
  • Company: Rosemont Pharms
  • Approval Date: 23 July 2025
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated:
    • for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
    • In patients 55 years or older at high risk of developing a major cardiovascular event, VOSTALLY is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes.
    • In adult patients with post-myocardial infarction heart failure to reduce the risk of cardiovascular death and hospitalization for heart failure
  • Approved Label:  23 July 2025 (PDF)
SDAMLO
  • Active Ingredient(s): Amlodipine Besylate
  • Strength: EQ 2.5MG BASE/BOT; EQ 5MG BASE/BOT; EQ 10MG BASE/BOT
  • Dosage Form(s) / Route(s): Solution;oral
  • Company: Brillian Pharma
  • Approval Date: 24 July 2025
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s):
    • Hypertension
      • Sdamlo is indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients 6 years of age and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions
    • Coronary Artery Disease in adults
      • 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 July 2025 (PDF)
DOPTELET SPRINKLE
  • Active Ingredient(s): Avatrombopag Maleate
  • Strength: EQ 10MG BASE
  • Dosage Form(s) / Route(s): Granule;oral
  • Company: Akarx Inc
  • Approval Date: 24 July 2025
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of:
    • Thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
    • Thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment
    • Thrombocytopenia in pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment
  • Approved Label:  24 July 2025 (PDF)
SEPHIENCE
  • Active Ingredient(s): Sepiapterin
  • Strength: 250MG/PACKET; 1GM/PACKET
  • Dosage Form(s) / Route(s): Powder;oral
  • Company: Ptc Therap
  • Approval Date: 28 July 2025
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU). SEPHIENCE is to be used in conjunction with a phenylalanine (Phe)restricted diet.
  • Approved Label:  28 July 2025 (PDF)
VYSCOXA
  • Active Ingredient(s): Celecoxib
  • Strength: 10MG/ML
  • Dosage Form(s) / Route(s): Suspension;oral
  • Company: Codadose Inc
  • Approval Date: 29 July 2025
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for:
    • In adults for
    • Osteoarthritis (OA)
    • Rheumatoid Arthritis (RA)
    • Ankylosing Spondylitis (AS)
    In pediatric patients two years and older for
    • Juvenile Rheumatoid Arthritis (JRA)
    Limitation of Use
    VYSCOXA must be administered on an empty stomach at least 2 hours before or 1 hour after food. Taking VYSCOXA with food results in plasma exposures of celecoxib up to 50% higher than intended. If patients cannot tolerate VYSCOXA in the fasted state, discontinue use of VYSCOXA
  • Approved Label:  29 July 2025 (PDF)
ATMEKSI
  • Active Ingredient(s): Methocarbamol
  • Strength: 750MG/5ML; 750MG(5ML)
  • Dosage Form(s) / Route(s): Suspension;oral
  • Company: Rosemont Pharms
  • Approval Date: 30 July 2025
  • Submission Classification: NA
  • Indication(s): Indicated as:
    • an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in patients 16 and older.
  • Approved Label:  30 July 2025 (PDF)
VIZZ
  • Active Ingredient(s): Aceclidine Hydrochloride
  • Strength: EQ 1.44% BASE
  • Dosage Form(s) / Route(s): Solution/drops;ophthalmic
  • Company: Lenz Therap
  • Approval Date: 31 July 2025
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of presbyopia in adults.
  • Approved Label:  31 July 2025 (PDF)
ALHEMO
  • Active Ingredient(s): Concizumab
  • Strength: 60MG/1.5ML (40MG/ML); 150MG/1.5ML (100MG/ML); 300MG/3ML (100MG/ML)
  • Dosage Form(s) / Route(s): Solution; Injection
  • Company: Novo Nordisk Inc
  • Approval Date: 31 July 2025
  • Submission Classification: NA
  • Indication(s): Indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with:
    • hemophilia A (congenital factor VIII deficiency) with or without FVIII inhibitors
    • hemophilia B (congenital factor IX deficiency) with or without FIX inhibitors
  • Approved Label:  31 July 2025 (PDF)