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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
Stephen Padilla, 28 Nov 2017
A dietary pattern rich in fresh and dried fruits, nuts and seeds, vegetable oils, and low-fat dairy products appears to lower the incidence rate of insulin resistance, according to an Iran study.
Pearl Toh, 20 Apr 2018
The investigational oral synthetic androgen dimethandrolone undecanoate (DMAU) suppresses serum testosterone levels to near castrate levels and appears safe when taken once daily for a month, showing potential as a male contraceptive pill, according to a study.
02 Aug 2018
Men and women who regularly eat seafood appear to have higher sexual intercourse frequency (SIF) and fecundity in a large prospective cohort of couples attempting pregnancy, suggests a study.
12 Apr 2018
In the context of low-glycaemic index (GI) dietary patterns, eating pasta does not contribute to adiposity and may even reduce body weight and body mass index (BMI) compared with higher-GI dietary patterns, a recent study has found.