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 (01 - 15 April 2020)

15 Apr 2020
New drug applications approved by US FDA as of 01 - 15 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.

KOSELUGO
  • Active Ingredient(s): Selumetinib
  • Strength: 10 mg; 25 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: AstraZeneca LP
  • Approval Date: 10 April 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
  • Approved Label10 April 2020 (PDF)

HELIUM, USP
  • Active Ingredient(s): Not available
  • Strength: Not available
  • Dosage Form(s) / Route(s): Gas; inhalataion
  • Company: ILMO Products Company
  • Approval Date: 14 April 2020
  • Submission Classification: Medical Gas
  • Indication(s): Not available
  • Approved Label: Not available

JELMYTO
  • Active Ingredient(s): Mitomycin
  • Strength: Not available
  • Dosage Form(s) / Route(s): Solution; pyelocalyceal
  • Company: Urogen Pharma, Ltd.
  • Approval Date: 15 April 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC).
  • Approved Label15 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.