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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 (16 - 31 March 2019)

02 Apr 2019
New drug applications approved by US FDA as of 16 - 31 March 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.

ZYKADIA
  • Active Ingredient(s): Ceritinib
  • Strength:150 mg
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Novartis Pharms Corp
  • Approval Date: 18 Mar 2019
  • Submission Classification: Not Available
  • Indication(s): Indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
  • Approved Label: 18 Mar 2019 (PDF)

ZULRESSO
  • Active Ingredient(s): Brexanolone
  • Strength: 5 mg/mL
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Sage Therapeutics
  • Approval Date: 19 Mar 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of postpartum depression (PPD) in adults.
  • Approved Label: 19 Mar 2019 (PDF)

MAYZENT
  • Active Ingredient(s): Siponimod
  • Strength: 0.25 mg; 2 mg
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Novartis Pharms Corp
  • Approval Date:  26 Mar 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • 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 adults.
  • Approved Label26 Mar 2019 (PDF)

JATENZO
  • Active Ingredient(s): Testosterone undecanoate
  • Strength: 237 mg
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: Clarus Therapeutics Inc
  • Approval Date: 27 Mar 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
  • Approved Label27 Mar 2019 (PDF)

DUAKLIR PRESSAIR
  • Active Ingredient(s): Aclidinium bromide; formoterol fumarate dihydrate
  • Strength: 400 mcg / 12 mcg
  • Dosage Form(s) / Route(s): Powder; Inhalation
  • Company: AstraZeneca Pharms
  • Approval Date: 29 Mar 2019
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
  • Approved Label29 Mar 2019 (PDF)
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Most Read Articles
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.