Most Read Articles
Tristan Manalac, 14 May 2020
Liver injuries appear to be more common in severe cases of coronavirus disease 2019 (COVID-19), a new meta-analysis reports.
16 May 2020
There appears to be no evidence of the SARS-CoV-2 virus in the semen of patients recovering from COVID-19 a month after diagnosis, according to a study, suggesting that the virus is unlikely to gain entry into testicular cells through an ACE2/TMPRSS2-mediated mechanism.
Stephen Padilla, Yesterday
Herd immunity will not work in the novel coronavirus disease (COVID-19), according to an infectious disease expert who addressed over 3,600 primary care physicians (PCP) from Asia Pacific at the inaugural webcast of the MIMS COVID Conversations Series.
Jairia Dela Cruz, 15 May 2020
In the fight against the coronavirus disease 2019 (COVID-19) pandemic, healthcare workers experience a range of physical symptoms, which are strongly related to psychological distress, according to a study, suggesting a bidirectional relationship between physical symptoms and psychological outcomes.

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
Tristan Manalac, 14 May 2020
Liver injuries appear to be more common in severe cases of coronavirus disease 2019 (COVID-19), a new meta-analysis reports.
16 May 2020
There appears to be no evidence of the SARS-CoV-2 virus in the semen of patients recovering from COVID-19 a month after diagnosis, according to a study, suggesting that the virus is unlikely to gain entry into testicular cells through an ACE2/TMPRSS2-mediated mechanism.
Stephen Padilla, Yesterday
Herd immunity will not work in the novel coronavirus disease (COVID-19), according to an infectious disease expert who addressed over 3,600 primary care physicians (PCP) from Asia Pacific at the inaugural webcast of the MIMS COVID Conversations Series.
Jairia Dela Cruz, 15 May 2020
In the fight against the coronavirus disease 2019 (COVID-19) pandemic, healthcare workers experience a range of physical symptoms, which are strongly related to psychological distress, according to a study, suggesting a bidirectional relationship between physical symptoms and psychological outcomes.