Most Read Articles
3 days ago
Ivermectin confers benefits in the treatment of COVID-19, with a recent study showing that its use helps reduce the risk of death especially in patients with severe pulmonary involvement.
3 days ago
Mental health comorbidities are common among patients with type 2 diabetes mellitus and may lead to worse outcomes, a recent study has found.
Roshini Claire Anthony, 13 Nov 2020

Diabetes is a key risk factor for heart failure (HF), which is the leading cause of hospitalization in patients with or without diabetes. SGLT-2* inhibitors (SGLT-2is) have been shown to reduce the risk of hospitalization for HF (HHF) regardless of the presence or absence of diabetes.

Tristan Manalac, 18 Nov 2020
The substitution of isoleucine to leucine at amino acid 97 (I97L) in the core region of the hepatitis B virus (HBV) seems to reduce its potency, decreasing the efficiency of both infection and the synthesis of the virus’ covalently closed circular (ccc) DNA, reports a new study presented at The Liver Meeting Digital Experience by the American Association for the Study of Liver Diseases (AASLD 2020).

Original New Drug Application Approvals by US FDA (16 - 31 May 2018)

31 May 2018

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

LUCEMYRA

  • Active Ingredient(s): Lofexidine
  • Strength: 0.18 MG
  • Dosage Form: Tablet
  • Company: US Worldmeds LLC
  • Approval Date: 16 May 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults
  • Approved Label16/05/2018 (PDF)
AIMOVIG
  • Active Ingredient(s): Erenumab-AOOE
  • Strength: 70 MG/ML
  • Dosage Form: Injectable
  • Company: Amgen Inc
  • Approval Date: 17 May 2018
  • Submission Classification: Not available
  • Indication(s): Indicated for the preventive treatment of migraine in adults
  • Approved Label17/05/2018 (PDF)
LOKELMA
  • Active Ingredient(s): Sodium zirconium cyclosilicate
  • Strength: 5 G; 10 G
  • Dosage Form: Powder for oral suspension
  • Company: AstraZeneca Pharms
  • Approval Date: 18 May 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for hyperkalemia in adults
  • Approved Label18/05/2018 (PDF)
DOPTELET
  • Active Ingredient(s): Avatrombopag
  • Strength: 20 MG
  • Dosage Form: Tablet
  • Company: Akarx Inc
  • Approval Date: 21 May 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure
  • Approved Label: 21/05/2018 (PDF)
YONSA
  • Active Ingredient(s): Abiraterone acetate
  • Strength: 125 MG
  • Dosage Form: Tablet
  • Company: Sun Pharma Global
  • Approval Date: 22 May 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer 
  • Approved Label: 22/05/2018 (PDF)
PROGRAF
  • Active Ingredient(s): Tacrolimus
  • Strength: 0.2 MG; 1 MG
  • Dosage Form: Suspension
  • Company: Astellas
  • Approval Date: 24 May 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants
  • Approved Label: 24/05/2018 (PDF)
HALOBETASOL PROPIONATE
  • Active Ingredient(s): Halobetasol propionate
  • Strength:0.05%
  • Dosage Form: Fiber, extended release; periodontal
  • Company: Therapeutics Inc
  • Approval Date: 25 May 2018
  • Submission Classification: Type 3 - New Dosage Form and Type 4 - New Combination
  • Indication(s): Indicated for the topical treatment of plaque psoriasis in patients eighteen (18) years of age and older
  • Approved Label: 24/05/2018 (PDF)
PALYNZIQ
  • Active Ingredient(s): Pegvaliasee-PQPZ
  • Strength: 2.5MG/O.5ML; 10MG/0.5ML; 20MG/ML
  • Dosage Form: Injectable
  • Company: Biomarin Pharm
  • Approval Date: 25 May 2018
  • Submission Classification: Not available
  • Indication(s): Indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management
  • Approved Label: 24/05/2018 (PDF)
IMVEXXY
  • Active Ingredient(s): Estradiol
  • Strength:4 MCG; 10 MCG
  • Dosage Form: Vaginal insert
  • Company: TherapeuticsMD Inc
  • Approval Date:29 May 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause
  • Approved Label: 29/05/2018 (PDF)
CONSENSI
  • Active Ingredient(s): Amlodipine; Celecoxib
  • Strength: (2.5 MG; 200 MG); (5 MG; 200 MG); (10 MG; 200 MG)
  • Dosage Form: Tablet
  • Company: Kitov Pharmaceuticals
  • Approval Date: 31 May 2018
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated for patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate
  • Approved Label: 31/05/2018 (PDF)
Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Oncology - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
3 days ago
Ivermectin confers benefits in the treatment of COVID-19, with a recent study showing that its use helps reduce the risk of death especially in patients with severe pulmonary involvement.
3 days ago
Mental health comorbidities are common among patients with type 2 diabetes mellitus and may lead to worse outcomes, a recent study has found.
Roshini Claire Anthony, 13 Nov 2020

Diabetes is a key risk factor for heart failure (HF), which is the leading cause of hospitalization in patients with or without diabetes. SGLT-2* inhibitors (SGLT-2is) have been shown to reduce the risk of hospitalization for HF (HHF) regardless of the presence or absence of diabetes.

Tristan Manalac, 18 Nov 2020
The substitution of isoleucine to leucine at amino acid 97 (I97L) in the core region of the hepatitis B virus (HBV) seems to reduce its potency, decreasing the efficiency of both infection and the synthesis of the virus’ covalently closed circular (ccc) DNA, reports a new study presented at The Liver Meeting Digital Experience by the American Association for the Study of Liver Diseases (AASLD 2020).