Most Read Articles
Dr Margaret Shi, 13 Jul 2020

An MRI-first diagnostic pathway, combined with risk-tailored screening, is shown to improve the benefit-to-harm profile and cost-effectiveness of screening for prostate cancer (PCa), according to results of a recent lifetable modelling study presented at AACR 2020 Virtual Meeting II.

Christina Lau, 14 Jul 2020

Flat-dose nivolumab, administered as a 30-minute infusion, is well tolerated and active in Asian patients with previously treated advanced non-small-cell lung cancer (NSCLC), according to results of the phase IIIb CheckMate 870 study.

Natalia Reoutova, 17 Jul 2020

At a median follow-up of 22.9 months, atezolizumab plus carboplatin and etoposide (CP/ET), given as a first-line treatment, continued to demonstrate an improvement in overall survival (OS) vs placebo plus CP/ET in patients with extensive-stage small-cell lung cancer (ES-SCLC), according to updated results of the IMpower133 trial presented at the American Association for cancer Research (AACR) 2020 Virtual Annual Meeting II.

13 Feb 2020
At the recent National Haematology Expert Meeting 2019, a panel of experts was convened to discuss the role of targeted therapy in the management of haematological malignancies. Highlights of their lectures are summarised below.

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, 13 Jul 2020

An MRI-first diagnostic pathway, combined with risk-tailored screening, is shown to improve the benefit-to-harm profile and cost-effectiveness of screening for prostate cancer (PCa), according to results of a recent lifetable modelling study presented at AACR 2020 Virtual Meeting II.

Christina Lau, 14 Jul 2020

Flat-dose nivolumab, administered as a 30-minute infusion, is well tolerated and active in Asian patients with previously treated advanced non-small-cell lung cancer (NSCLC), according to results of the phase IIIb CheckMate 870 study.

Natalia Reoutova, 17 Jul 2020

At a median follow-up of 22.9 months, atezolizumab plus carboplatin and etoposide (CP/ET), given as a first-line treatment, continued to demonstrate an improvement in overall survival (OS) vs placebo plus CP/ET in patients with extensive-stage small-cell lung cancer (ES-SCLC), according to updated results of the IMpower133 trial presented at the American Association for cancer Research (AACR) 2020 Virtual Annual Meeting II.

13 Feb 2020
At the recent National Haematology Expert Meeting 2019, a panel of experts was convened to discuss the role of targeted therapy in the management of haematological malignancies. Highlights of their lectures are summarised below.