Most Read Articles
Roshini Claire Anthony, 11 Sep 2019

Beta-blockers could reduce mortality risk in patients with heart failure with reduced ejection fraction (HFrEF) and moderate or moderately-severe renal dysfunction without causing harm, according to the BB-META-HF* trial presented at ESC 2019.

Elvira Manzano, 16 hours ago

The US Preventive Services Task Force (USPSTF), in an update of its 2013 recommendations, called on clinicians to offer risk-reducing medications to women who are at increased risk for breast cancer but at low risk for adverse effects.

Pearl Toh, Yesterday
The use of SGLT-2* inhibitors was not associated with a higher risk of severe or nonsevere urinary tract infections (UTIs) in patients with type 2 diabetes (T2D) compared with DPP**-4 inhibitors or GLP-1*** receptor agonists, a population-based cohort study shows.
Stephen Padilla, 6 days ago
Overweight and obesity show an inverse relationship with acne in a dose-dependent manner in young adults, according to a recent study. This suggests that the metabolically active adipose tissue plays a protective role in acne.

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, 11 Sep 2019

Beta-blockers could reduce mortality risk in patients with heart failure with reduced ejection fraction (HFrEF) and moderate or moderately-severe renal dysfunction without causing harm, according to the BB-META-HF* trial presented at ESC 2019.

Elvira Manzano, 16 hours ago

The US Preventive Services Task Force (USPSTF), in an update of its 2013 recommendations, called on clinicians to offer risk-reducing medications to women who are at increased risk for breast cancer but at low risk for adverse effects.

Pearl Toh, Yesterday
The use of SGLT-2* inhibitors was not associated with a higher risk of severe or nonsevere urinary tract infections (UTIs) in patients with type 2 diabetes (T2D) compared with DPP**-4 inhibitors or GLP-1*** receptor agonists, a population-based cohort study shows.
Stephen Padilla, 6 days ago
Overweight and obesity show an inverse relationship with acne in a dose-dependent manner in young adults, according to a recent study. This suggests that the metabolically active adipose tissue plays a protective role in acne.