Most Read Articles
Roshini Claire Anthony, 12 Apr 2018

Individuals with severe obesity who undergo Roux-en-Y gastric bypass (RYGB) may have a higher risk of nonvertebral fractures than those who undergo adjustable gastric banding (AGB), according to a study presented at the recent ENDO 2018 sessions.

Original New Drug Application Approvals by US FDA (16 - 31 December 2017)

31 Dec 2017

New drug applications approved by US FDA as of 16-31 December 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.

RHOPRESSA

  • Active Ingredient(s): Netarsudil
  • Strength: 0.02%
  • Dosage Form: Solution; Opthalmic
  • Company: Aerie Pharmaceuticals Inc
  • Approval Date: December 18, 2017
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
  • Approved Label: 12/18/2017(PDF)

PREXXARTAN
  • Active Ingredient(s): Valsartan
  • Strength: 4mg/ml
  • Dosage Form: Solution;oral
  • Company: Carmel Biosciences Inc
  • Approval Date: December 19, 2017
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for 
    • Hypertension in adults and children six years and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
    • Heart failure (NYHA class II-IV); PREXXARTAN significantly reduces hospitalization for heart failure in patients who are unable to swallow valsartan tablets.
    • Stable left ventricular failure or left ventricular dysfunction following myocardial infarction; PREXXARTAN reduces cardiovascular mortality in patients who are unable to swallow valsartan tablets.
  • Approved Label: 12/19/2017(PDF)

STEGLATRO
  • Active Ingredient(s): Ertugliflozin
  • Strength: 5 mg,15 mg 
  • Dosage Form: Tablet; oral
  • Company: Merck Sharp Dohme
  • Approval Date: December 19, 2017
  • Submission Classification: Labeling
  • Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Approved Label: 12/19/2017(PDF)

STEGLUJAN
  • Active Ingredient(s): Ertugliflozin; Sitagliptin
  • Strength: 500 mg; 100 mg, 15 mg;100 mg
  • Dosage Form: Tablet; oral
  • Company: Merck Sharp Dohme
  • Approval Date: December 19, 2017
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate.
  • Approved Label: 12/19/2017(PDF)

SEGLUROMET
  • Active Ingredient(s): Ertugliflozin; Metformin Hydrochloride
  • Strength: 2.5 mg; 500 mg, 2.5 mg; 1000 mg, 7.5 mg; 500 mg, 7.5 mg; 1000 mg
  • Dosage Form: Tablet; oral
  • Company: Merck Sharp Dohme
  • Approval Date: December 19, 2017
  • Submission Classification: Labeling
  • Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing ertugliflozin or metformin, or in patients who are already treated with both ertugliflozin and metformin. 
  • Approved Label: 12/19/2017(PDF)

MACRILEN
  • Active Ingredient(s): Macimorelin
  • Strength: 0.5 mg
  • Dosage Form: Solution;oral
  • Company: Aeterna Zentaris GMBH
  • Approval Date: December 20, 2017
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the diagnosis of adult growth hormone deficiency
  • Approved Label: 12/20/2017(PDF)

SIKLOS
  • Active Ingredient(s): Hydroxyuera 
  • Strength: 100 mg, 1000 mg
  • Dosage Form: Tablet;oral
  • Company: Addmedica SAS
  • Approval Date: December 21, 2017
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises. 
  • Approved Label: 12/21/2017(PDF)

GIAPREZA
  • Active Ingredient(s):Angiotensin II
  • Strength: 25 mg/ml
  • Dosage Form: Injectable; injection
  • Company: LA Jolla Pharmaceutical Co
  • Approval Date: December 21, 2017
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated to increase blood pressure in adults with septic or other distributive shock.
  • Approved Label: 12/21/2017(PDF)

LUMIFY
  • Active Ingredient(s): Brimonidine Tartrate
  • Strength: 0.025%
  • Dosage Form: Solution; Opthalmic
  • Company: Bausch & Lomb
  • Approval Date: December 22, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated relieve redness of the eye due to minor eye irritations
  • Approved Label: 12/22/2017(PDF)
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Most Read Articles
Roshini Claire Anthony, 12 Apr 2018

Individuals with severe obesity who undergo Roux-en-Y gastric bypass (RYGB) may have a higher risk of nonvertebral fractures than those who undergo adjustable gastric banding (AGB), according to a study presented at the recent ENDO 2018 sessions.