Most Read Articles
12 Jun 2020
Drawing from experience as a key investigator in landmark clinical trials (including PALOMA, MONALEESA and MONARCH), and his clinical experience with CDK4/6 inhibitors, Dr Rafael Villanueva Vázquez shares his insights into the current evidence of using CDK4/6 inhibitors to treat HR+/HER2- ABC.
Dr Margaret Shi, 14 May 2020
Pembrolizumab monotherapy improves overall survival (OS) and cancer control compared with platinum-based chemotherapy in patients with untreated locally advanced or metastatic programmed death-ligand 1 (PD-L1)–positive non-small-cell lung cancer (NSCLC) regardless of STK11 or KEAP1 mutation status, according to results of the phase III KEYNOTE-042 study. 

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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Editor's Recommendations
Most Read Articles
12 Jun 2020
Drawing from experience as a key investigator in landmark clinical trials (including PALOMA, MONALEESA and MONARCH), and his clinical experience with CDK4/6 inhibitors, Dr Rafael Villanueva Vázquez shares his insights into the current evidence of using CDK4/6 inhibitors to treat HR+/HER2- ABC.
Dr Margaret Shi, 14 May 2020
Pembrolizumab monotherapy improves overall survival (OS) and cancer control compared with platinum-based chemotherapy in patients with untreated locally advanced or metastatic programmed death-ligand 1 (PD-L1)–positive non-small-cell lung cancer (NSCLC) regardless of STK11 or KEAP1 mutation status, according to results of the phase III KEYNOTE-042 study.