Original New Drug Application Approvals by US FDA (1 - 15 December 2022)

New drug applications approved by US FDA as of 01 - 15 December 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.

REZLIDHIA

• Active Ingredient(s): Olutasidenib
• Strength: 150MG
• Dosage Form(s) / Route(s): Capsule;oral
• Company: Rigel Pharms Inc
• Approval Date: 01 December 2022
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.
• Approved Label:  01 December (PDF)

TASCENSO ODT

• Active Ingredient(s): Fingolimod Lauryl Sulfate
• Strength: Eq 0.25mg Base
• Dosage Form(s) / Route(s): Tablet, Orally Disintegrating;oral
• Company: Handa
• Approval Date: 09 December 2022
• Submission Classification: Type 2 - New Active Ingredient
• Indication(s): Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.
• Approved Label:  09 December (PDF)

KRAZATI

• Active Ingredient(s): Adagrasib
• Strength: 200MG
• Dosage Form(s) / Route(s): Tablet;oral
• Company: Mirati Therapeutics, Inc
• Approval Date: 12 December 2022
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy.
  
  This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).
• Approved Label:  12 December (PDF)

IDACIO

• Active Ingredient(s): Adalimumab-aacf
• Strength: 40MG/0.8ML
• Dosage Form(s) / Route(s): Injectable;subcutaneous
• Company: Fresenius Kabi USA
• Approval Date: 13 December 2022
• Submission Classification: Not Applicable
• Indication(s): Indicated for:
  • Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
  • Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
  • Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
  • Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
  • Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
  • Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adult patients.
    Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
  • Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
• Approved Label:  13 December (PDF)