Most Read Articles
Roshini Claire Anthony, 03 Sep 2018

The rate of syphilis reactivity appears to be higher in individuals with dementia compared with those without the condition, a Singapore study has found.

12 Jun 2019
Urogenital infections remain a major reason for women to visit their family physician and their subsequent referral to obstetrics and gynaecology or urology specialists. The association between abnormal vaginal microbiota and an increased risk of contracting sexually transmitted diseases (STDs), as well as an increased rate of preterm labour, indicates the need to better understand and manage urogenital health in women. Probiotics are “live microorganisms which, when administered in adequate amounts, confer a health benefit on the host”. As such, there is a sound rationale for using probiotics to maintain female vaginal and bladder health.
Tristan Manalac, Yesterday
Elderly coronavirus disease 2019 (COVID-19) patients with high nutritional risk appear to suffer worse outcomes, such as longer hospital stay and greater disease severity, according to a recent study.
Jairia Dela Cruz, 16 Apr 2020
The odds of women passing coronavirus disease 2019 (COVID-19) to their sexual partners appear to be low, with two studies showing no evidence of the disease-causing SARS-CoV-2 virus existing in the vaginal fluids of infected patients.

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
Roshini Claire Anthony, 03 Sep 2018

The rate of syphilis reactivity appears to be higher in individuals with dementia compared with those without the condition, a Singapore study has found.

12 Jun 2019
Urogenital infections remain a major reason for women to visit their family physician and their subsequent referral to obstetrics and gynaecology or urology specialists. The association between abnormal vaginal microbiota and an increased risk of contracting sexually transmitted diseases (STDs), as well as an increased rate of preterm labour, indicates the need to better understand and manage urogenital health in women. Probiotics are “live microorganisms which, when administered in adequate amounts, confer a health benefit on the host”. As such, there is a sound rationale for using probiotics to maintain female vaginal and bladder health.
Tristan Manalac, Yesterday
Elderly coronavirus disease 2019 (COVID-19) patients with high nutritional risk appear to suffer worse outcomes, such as longer hospital stay and greater disease severity, according to a recent study.
Jairia Dela Cruz, 16 Apr 2020
The odds of women passing coronavirus disease 2019 (COVID-19) to their sexual partners appear to be low, with two studies showing no evidence of the disease-causing SARS-CoV-2 virus existing in the vaginal fluids of infected patients.