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Original New Drug Application Approvals by US FDA (16 - 31 October 2019)

31 Oct 2019
New drug application approved by US FDA as of 16 - 31 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.

AMZEEQ
  • Active Ingredient(s): Minocycline
  • Strength: 4%
  • Dosage Form(s) / Route(s):Aerosol, foam; topical
  • Company: Foamix Pharma, Inc.
  • Approval Date: 18 October 2019
  • Submission Classification: Not available
  • Indication(s): Indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
  • Approved Label18 October 2019 (PDF)

TRIKAFTA
  • Active Ingredient(s): Elexacaftor, tezacaftor, ivacaftor; ivacaftor
  • Strength: 100 mg, 75 mg, 50 mg; 150 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Vertex Pharms, Inc.
  • Approval Date: 21 October 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the CFTR gene. If the patients's genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one F508del mutation.
  • Approved Label21 October 2019 (PDF)

BIORPHEN
  • Active Ingredient(s): Phenylephrine hydrochloride
  • Strength: 0.1 mg/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Sintetica SA
  • Approval Date: 21 October 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
  • Approved Label21 October 2019 (PDF)

VUMERITY
  • Active Ingredient(s): Diroximel fumarate
  • Strength: 231 mg
  • Dosage Form(s) / Route(s): Capsule, delayed release; oral
  • Company: Alkermes
  • Approval Date: 29 October 2019
  • Submission Classification: Type 2 - New Active Ingredient
  • 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 Label29 October 2019 (PDF)
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Most Read Articles
21 Nov 2020
Ivermectin confers benefits in the treatment of COVID-19, with a recent study showing that its use helps reduce the risk of death especially in patients with severe pulmonary involvement.
6 days ago
Mental health comorbidities are common among patients with type 2 diabetes mellitus and may lead to worse outcomes, a recent study has found.
Roshini Claire Anthony, 13 Nov 2020

Diabetes is a key risk factor for heart failure (HF), which is the leading cause of hospitalization in patients with or without diabetes. SGLT-2* inhibitors (SGLT-2is) have been shown to reduce the risk of hospitalization for HF (HHF) regardless of the presence or absence of diabetes.

3 days ago
Vitamin D deficiency may be a contributing factor to the mortality rate among patients with the novel coronavirus disease (COVID-19), reports a new study.