Original New Drug Application Approvals by US FDA (16-31 March 2026)

New drug applications approved by US FDA as of 16-31 March 2026 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.

ICOTYDE

• Active Ingredient(s): Icotrokinra Hydrochloride
• Strength: EQ 200MG BASE
• Dosage Form(s) / Route(s): Tablet;oral
• Company: Janssen Biotech
• Approval Date: 17 March 2026
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy.
• Approved Label:  17 March 2026 (PDF)

LYNAVOY

• Active Ingredient(s): Linerixibat
• Strength: 40MG
• Dosage Form(s) / Route(s): Tablet;oral
• Company: GlaxoSmithKline
• Approval Date: 17 March 2026
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients.
  Limitations of Use
  Avoid use of LYNAVOY in patients with decompensated cirrhosis or those with prior or active hepatic decompensation events (e.g. variceal hemorrhage, ascites, hepatic encephalopathy).
• Approved Label:  17 March 2026 (PDF)

ATONCY

• Active Ingredient(s): Atomoxetine Hydrochloride
• Strength: EQ 4MG BASE/ML
• Dosage Form(s) / Route(s): Solution;oral
• Company: Map77
• Approval Date: 20 March 2026
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for the treatment of ADHD in adults and pediatric patients 6 years of age and older.
• Approved Label:  20 March 2026 (PDF)

AVLAYAH

• Active Ingredient(s): Tividenofusp Alfa-eknm
• Strength: 150MG/VIAL
• Dosage Form(s) / Route(s): Injection;powder,for Solution
• Company: Denali Therapeutics INC.
• Approval Date: 24 March 2026
• Submission Classification: NA
• Indication(s): Indicated for the treatment of neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II, MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment.
  This indication is approved under accelerated approval based on reduction of cerebrospinal fluid heparan sulfate observed in patients treated with AVLAYAH. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).
  Limitations of Use
  AVLAYAH is not recommended for use in combination with other enzyme replacement therapies.
• Approved Label:  24 March 2026 (PDF)

PONLIMSI

• Active Ingredient(s): Denosumab-adet
• Strength: 60MG/ML
• Dosage Form(s) / Route(s): Injectable;subcutaneous
• Company: Teva Pharmaceuticals, INC.
• Approval Date: 27 March 2026
• Submission Classification: NA
• Indication(s): Indicated for treatment:
  • of postmenopausal women with osteoporosis at high risk for fracture
  • to increase bone mass in men with osteoporosis at high risk for fracture
  • of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
  • to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
  • to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
• Approved Label:  27 March 2026 (PDF)