Most Read Articles
Dr Margaret Shi, 02 Jan 2020

Tivozanib as third- or fourth-line therapy improves progression-free survival (PFS) compared with sorafenib in patients with metastatic renal cell carcinoma (mRCC) who have received ≥2 previous systemic treatments, according to results of the phase III, randomized, controlled TIVO-3 trial.

Original New Drug Application Approvals by US FDA (01 - 15 October 2019)

15 Oct 2019
New drug applications approved by US FDA as of 01 - 15 October 2019 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.

HEMADY
  • Active Ingredient(s): Dexamethasone
  • Strength: 20 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Dexcel Pharma
  • Approval Date: 03 October 2019
  • Submission Classification: Not available
  • Indication(s): Indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma.
  • Approved Label03 October 2019 (PDF)

AKLIEF
  • Active Ingredient(s): Trifarotene
  • Strength: 0.005%
  • Dosage Form(s) / Route(s): Cream; topical
  • Company: Galderma Research and Dev, Inc.
  • Approval Date: 04 October 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the topical treatment of acne vulgaris in patient 9 year of age and older.
  • Approved Label04 October 2019 (PDF)

BORTEZOMIB
  • Active Ingredient(s): Bortezomib
  • Strength: 3.5 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Dr. Reddy's Labs, Inc.
  • Approval Date: 04 October 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for:
    • treatment of adult patients with multiple myeloma.
    • treatment of adult patients with mantle cell lymphoma who have received at least 1 prior therapy.
  • Approved Label04 October 2019 (PDF)

QUZYTTIR
  • Active Ingredient(s): Cetirizine hydrochloride
  • Strength: 10 mg/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: JDP Therapeutics, Inc.
  • Approval Date: 04 October 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of acute urticaria in adults and children 6 months of age and older.
  • Approved Label04 October 2019 (PDF)

BONSITY
  • Active Ingredient(s): Teriparatide
  • Strength: 20 mcg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Pfenex, Inc.
  • Approval Date: 04 October 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for:
    • Treatment of postmenopausal women with osteoporosis at high risk for fracture.
    • Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture.
    • Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.
  • Approved Label04 October 2019 (PDF)

BEOVU
  • Active Ingredient(s): Brolucizumab-dbll
  • Strength: 6 mg/0.5 mL
  • Dosage Form(s) / Route(s): Injectable; intravitreal
  • Company: Novartis Pharms Corp.
  • Approval Date: 07 October 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (AMD).
  • Approved Label07 October 2019 (PDF)

SCENESSE
  • Active Ingredient(s): Afamelanotide
  • Strength: 16 mg
  • Dosage Form(s) / Route(s): Implant; subcutaneous
  • Company: Clinuvel, Inc.
  • Approval Date: 08 October 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).
  • Approved Label08 October 2019 (PDF)

FLUORODEOXYPHENYLALANINE ([18F]-DOPA)
  • Active Ingredient(s): Fluorodeoxyphenylalanine
  • Strength: 185 MBq
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Feinstein
  • Approval Date: 10 October 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes (PS). Fluorodopa F 18 PET is an adjunct to other diagnostic evaluations.
  • Approved Label10 October 2019 (PDF)

REYVOW
  • Active Ingredient(s): Lasmiditan succinate
  • Strength: 50 mg; 100 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Eli Lilly and Co.
  • Approval Date: 11 October 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the acute treatment of migraine with or without aura in adults.
  • Approved Label11 October 2019 (PDF)

SECUADO
  • Active Ingredient(s): Asenapine
  • Strength: 3.8 mg; 5.7 mg; 7.6 mg
  • Dosage Form(s) / Route(s): System; transdermal
  • Company: Hisamitsu Pharm, Co.
  • Approval Date: 11 October 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Not available
  • Approved Label: Not available
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Most Read Articles
Dr Margaret Shi, 02 Jan 2020

Tivozanib as third- or fourth-line therapy improves progression-free survival (PFS) compared with sorafenib in patients with metastatic renal cell carcinoma (mRCC) who have received ≥2 previous systemic treatments, according to results of the phase III, randomized, controlled TIVO-3 trial.