Most Read Articles
15 Feb 2019
New drug applications approved by US FDA as of 01- 15 February 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.
Pearl Toh, 23 Aug 2018
Restoration of CD4/CD8 ratio on combination antiretroviral therapy (cART) was associated with decreased risk of Kaposi sarcoma (KS) while baseline CD8 count was related to non-Hogkin lymphoma (NHL) risk in people living with HIV (PLHIV) who had achieved viral suppression on cART, according to the COHERE* study presented at the AIDS International Conference (AIC) 2018.

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
15 Feb 2019
New drug applications approved by US FDA as of 01- 15 February 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.
Pearl Toh, 23 Aug 2018
Restoration of CD4/CD8 ratio on combination antiretroviral therapy (cART) was associated with decreased risk of Kaposi sarcoma (KS) while baseline CD8 count was related to non-Hogkin lymphoma (NHL) risk in people living with HIV (PLHIV) who had achieved viral suppression on cART, according to the COHERE* study presented at the AIDS International Conference (AIC) 2018.