Most Read Articles
13 Aug 2019
Individuals with obesity are at an elevated risk of developing infections, particularly that of the skin in both men and women, and those of the gastrointestinal and urinary tracts and sepsis in women only, according to a study.
6 days ago
An increase in intensive care unit (ICU) management and bacterial pneumonia development occurs in children with special risk medical conditions (SRMC), but a rise in the probability of death or need for mechanical ventilation remains inconsistent, suggests a recent study.
Pearl Toh, 30 Aug 2019
Oral amoxicillin–clavulanate effectively promotes resolution of nonsevere acute exacerbations in children with non-cystic fibrosis (CF) bronchiectasis, thus confirming the role of amoxicillin–clavulanate as first-line treatment for bronchiectasis, according to results from the three-arm BEST-1 study.

Original New Drug Application Approvals by US FDA (1 - 15 October 2018)

15 Oct 2018

New drug applications approved by US FDA as of 1-15 October 2018 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.

SEYSARA

  • Active Ingredient(s): Sarecycline
  • Strength: 60 mg, 100 mg, 150 mg
  • Dosage Form: Tablet; oral
  • Company: Allergan Inc
  • Approval Date: October 01, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for  the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
  • Approved Label: 10/01/2018(PDF)
NUZYRA
  • Active Ingredient(s): Omadacycline
  • Strength: 150 mg
  • Dosage Form: Tablet; oral
  • Company: Paratek Pharms Inc
  • Approval Date: October 02, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms 
  • Approved Label: 10/02/2018(PDF)
NUZYRA
  • Active Ingredient(s): Omadacycline
  • Strength: 100 mg
  • Dosage Form: Injectable; injection
  • Company: Paratek Pharms Inc
  • Approval Date: 10/02/2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms 
  • Approved Label:10/02/2018(PDF)
TEGSEDI
  • Active Ingredient(s): Inotersen
  • Strength: 189 mg/mL
  • Dosage Form: Injectabe; injection
  • Company: Ionis Pharms Inc
  • Approval Date: October 05, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
  • Approved Label: 10/05/2018(PDF)
REVCOVI
  • Active Ingredient(s): Elapegadema - LVLR
  • Strength: 1.6 mg/mL
  • Dosage Form: Injectable; Injection
  • Company: Leadiant Biosci Inc
  • Approval Date: October 05, 2018
  • Submission Classification: Not Applicable
  • Indication(s): Indicated for  the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.
  • Approved Label: 10/05/2018(PDF)
YUTIQ
  • Active Ingredient(s): Fluocinolone Acetonide
  • Strength: 0.18 mg
  • Dosage Form: Implant; implantation
  • Company: Eyepoint Pharms
  • Approval Date: October 12, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not Available
  • Approved Label: Not Available
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Most Read Articles
13 Aug 2019
Individuals with obesity are at an elevated risk of developing infections, particularly that of the skin in both men and women, and those of the gastrointestinal and urinary tracts and sepsis in women only, according to a study.
6 days ago
An increase in intensive care unit (ICU) management and bacterial pneumonia development occurs in children with special risk medical conditions (SRMC), but a rise in the probability of death or need for mechanical ventilation remains inconsistent, suggests a recent study.
Pearl Toh, 30 Aug 2019
Oral amoxicillin–clavulanate effectively promotes resolution of nonsevere acute exacerbations in children with non-cystic fibrosis (CF) bronchiectasis, thus confirming the role of amoxicillin–clavulanate as first-line treatment for bronchiectasis, according to results from the three-arm BEST-1 study.