Original New Drug Application Approvals by US FDA (01 - 15 July 2020)

15 Jul 2020
Original New Drug Application Approvals by US FDA (01 - 15 July 2020)
New drug applications approved by US FDA as of 01 - 15 July 2020 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.

TRALEMENT
  • Active Ingredient(s): Trace element
  • Strength: 1 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: American Regent, Inc.
  • Approval Date: 02 July 2020
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated in adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutririon when oral or enteral nutrition is not possible, insufficient, or contraindicated.
  • Approved Label: 02 July 2020 (PDF)

BYFAVO
  • Active Ingredient(s): Remimazolam
  • Strength: 20 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Cosmo Technologies, Ltd.
  • Approval Date: 02 July 2020
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.
  • Approved Label: 02 July 2020 (PDF)

RUKOBIA
  • Active Ingredient(s): Fostemsavir
  • Strength: 600 mg
  • Dosage Form(s) / Route(s): Tablet, extended release; oral
  • Company: Viiv Healthcare
  • Approval Date: 02 July 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
  • Approved Label: 02 July 2020 (PDF)

QWO
  • Active Ingredient(s): Collagenase clostridium histolyticum-aaes
  • Strength: Not available
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Endo Global Aesthetics, Ltd.
  • Approval Date: 06 July 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of moderate to severe cellulite in the buttocks of adult women.
  • Approved Label: 06 July 2020 (PDF)

HULIO
  • Active Ingredient(s): Adalimumab-fkjp
  • Strength: 20 mg; 0.4 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Mylan Pharms, Inc.
  • Approval Date: 06 July 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for treatment of:
    • 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 4 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.
    • Adult Crohn's Disease (CD): Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab products.
    • Ulcerative Colitis (UC): Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroid, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers.
    • Plaque Psoriasis (Ps): The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidate for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
  • Approved Label: 06 July 2020 (PDF)

INQOVI
  • Active Ingredient(s): Decitabine; cedazuridine
  • Strength: 35 mg; 100 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Astex Pharmaceuticals, Inc.
  • Approval Date: 07 July 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for treatment of adult patients with myelodysplatic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
  • Approved Label: 07 July 2020 (PDF)

UPNEEQ
  • Active Ingredient(s): Oxymetazoline hydrochloride
  • Strength: 0.1%
  • Dosage Form(s) / Route(s): Solution; opthalmic
  • Company: RVL Pharma, Inc.
  • Approval Date: 08 July 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of acquired blepharoptosis in adults.
  • Approved Label: 08 July 2020 (PDF)