Most Read Articles
Christina Lau, 14 Oct 2019

Denosumab can be of benefit to patients with unresectable giant cell tumour of bone (GCTB) and those who are likely to experience significant morbidity after surgical resection of GCTB.

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
Christina Lau, 14 Oct 2019

Denosumab can be of benefit to patients with unresectable giant cell tumour of bone (GCTB) and those who are likely to experience significant morbidity after surgical resection of GCTB.