Most Read Articles
5 days ago
Routinely used for treating cardiovascular diseases, statins have been shown to benefit other conditions, and new evidence suggests that using the drug at high intensity reduces the risk of hip or knee replacement, an effect that may be specific to rheumatoid arthritis.
Jairia Dela Cruz, 6 days ago
Following vegan and vegetarian diets, which offer plenty of what is good for health, has been reported to have a downside: an increased risk of depression and anxiety, especially for younger adults.
Pearl Toh, 29 Jun 2020
Having migraine during midlife appears to be associated with a higher risk of developing dementia in later life, according to a large population-based longitudinal Danish study presented at the AHS* 2020 Virtual Meeting, indicating that migraine may be a risk factor for dementia.
Roshini Claire Anthony, 3 days ago

Upadacitinib may be a suitable treatment for patients with active psoriatic arthritis (PsA) who have insufficient response to non-biologic disease-modifying anti-rheumatic drugs (non-bDMARDs), according to results of the phase III SELECT-PsA-1* trial presented at EULAR 2020.

Original New Drug Application Approvals by US FDA (16 - 30 April 2020)

29 Apr 2020
New drug applications approved by US FDA as of 16 - 30 April 2020 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.

EMERPHED
  • Active Ingredient(s): Ephedrine sulfate
  • Strength: 50 mg/10 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Nexus Pharms
  • Approval Date: 17 April 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
  • Approved Label17 April 2020 (PDF)

TUKYSA
  • Active Ingredient(s): Tucatinib
  • Strength: 50 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Seattle Genetics
  • Approval Date: 17 April 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable  or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
  • Approved Label17 April 2020 (PDF)

PEMAZYRE
  • Active Ingredient(s): Pemigatinib
  • Strength: 4.5 mg; 9 mg; 13.5 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Incyte Corp.
  • Approval Date: 17 April 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adults with previously treated, unresectable locally advances or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
  • Approved Label17 April 2020

TRODELVY
  • Active Ingredient(s): Sacituzumab govitecan-hziy
  • Strength: 180 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Immuomedics, Inc.
  • Approval Date: 22 April 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.
  • Approved Label22 April 2020 (PDF)

ONGENTYS
  • Active Ingredient(s): Opicapone
  • Strength: 25 mg; 50 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Neurocrine
  • Approval Date: 24 April 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes.
  • Approved Label24 April 2020 (PDF)

MILPROSA
  • Active Ingredient(s): Progesterone
  • Strength: 1.78 g
  • Dosage Form(s) / Route(s): Ring; vaginal
  • Company: Ferring Pharmaceutical, Inc.
  • Approval Date: 29 April 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated to support embryo implantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.
  • Approved Label29 April 2020 (PDF)
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Most Read Articles
5 days ago
Routinely used for treating cardiovascular diseases, statins have been shown to benefit other conditions, and new evidence suggests that using the drug at high intensity reduces the risk of hip or knee replacement, an effect that may be specific to rheumatoid arthritis.
Jairia Dela Cruz, 6 days ago
Following vegan and vegetarian diets, which offer plenty of what is good for health, has been reported to have a downside: an increased risk of depression and anxiety, especially for younger adults.
Pearl Toh, 29 Jun 2020
Having migraine during midlife appears to be associated with a higher risk of developing dementia in later life, according to a large population-based longitudinal Danish study presented at the AHS* 2020 Virtual Meeting, indicating that migraine may be a risk factor for dementia.
Roshini Claire Anthony, 3 days ago

Upadacitinib may be a suitable treatment for patients with active psoriatic arthritis (PsA) who have insufficient response to non-biologic disease-modifying anti-rheumatic drugs (non-bDMARDs), according to results of the phase III SELECT-PsA-1* trial presented at EULAR 2020.