Most Read Articles
Roshini Claire Anthony, 6 days ago

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.

Prof. Vincent Wong, Prof. Ray Kim, Dr. Tan Poh Seng, 10 Sep 2019
Chronic hepatitis B (CHB) remains a major public health concern because of its worldwide distribution and potential adverse sequelae, including cirrhosis and hepatocellular carcinoma (HCC). At a recent symposium held during the GIHep Singapore 2019, Professor Vincent Wong from the Chinese University of Hong Kong and Professor Ray Kim from the Stanford University School of Medicine, Stanford, California, US, discussed antiviral treatments for CHB, with a focus on the novel agent tenofovir alafenamide (Vemlidy®). Dr Tan Poh Seng from the National University Hospital, Singapore, chaired the symposium.
11 Sep 2019
Blood pressure (BP) in children is influenced by early-life exposure to several chemicals, built environment and meteorological factors, suggests a study.
Pearl Toh, 18 hours ago
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.

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

31 Aug 2018

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

LOPINAVIR; RITONAVIR

  • Active Ingredient(s): Lopinavir; Ritonavir
  • Strength:  unknown
  • Dosage Form: unknown
  • Company: Mylan Labs Ltd
  • Approval Date: August 16, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not Applicable
  • Approved Label: Not Applicable
DIACOMIT
  • Active Ingredient(s): Stiripentol
  • Strength: 250 mg; 500 mg
  • Dosage Form: Capsule; oral
  • Company: Biocodex SA
  • Approval Date: August 20, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam.
  • Approved Label: 08/20/2018(PDF)
DIACOMIT
  • Active Ingredient(s): Stiripentol
  • Strength: 250 mg; 500 mg
  • Dosage Form: Powder; oral
  • Company: Biocodex SA
  • Approval Date: August 20, 2018
  • Submission Classification:Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam.
  • Approved Label: 08/20/2018(PDF)
INVELTYS
  • Active Ingredient(s): Loteprednol Etabonate
  • Strength: 1%
  • Dosage Form: Suspension; ophthalmic
  • Company: Kala Pharms Inc
  • Approval Date: August 22, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of post-operative inflammation and pain following ocular surgery.
  • Approved Label: 08/22/2018(PDF)
OXERVATE
  • Active Ingredient(s): Cenegermin-BKBJ
  • Strength: 0.002% (20 mcg/ml)
  • Dosage Form: Solution; ophthalmic
  • Company: Dompe Farmaceutici
  • Approval Date: August 22, 2018
  • Submission Classification: Not Applicable
  • Indication(s): Indicated for the treatment of neurotrophic keratitis.
  • Approved Label: 08/22/2018(PDF)
ALTRENO
  • Active Ingredient(s): Tretinoin
  • Strength: 0.05%
  • Dosage Form: Lotion; topical
  • Company: Dow Pharma
  • Approval Date: August 23, 2018
  • Submission Classification: Not applicable
  • Indication(s): Indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. 
  • Approved Label: 08/23/2018(PDF)
TAKHZYRO
  • Active Ingredient(s): Lanadelumab(SHP643)
  • Strength: 300 mg/ml (150 mg/ml)
  • Dosage Form: Injectable; injection
  • Company: Dyax Corp
  • Approval Date: August 23, 2018
  • Submission Classification: Not applicable
  • Indication(s): Indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years and older. (1)
  • Approved Label: 08/23/2018(PDF)
XERAVA
  • Active Ingredient(s): Eravacycline
  • Strength: 50 mg
  • Dosage Form: Injectable; injection
  • Company: Tetraphase Pharms Inc
  • Approval Date:  August 27, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of complicated intra-abdominal infections in patients 18 years of age and older. 
  • Approved Label: 08/27/2018(PDF)
PIFELTRO
  • Active Ingredient(s): Doravirine
  • Strength: 100 mg
  • Dosage Form: Tablet; oral
  • Company: Merck Sharp Dohme
  • Approval Date: August 30, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated  in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment history.
  • Approved Label: 08/30/2018(PDF)
DELSTRIGO
  • Active Ingredient(s): Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate
  • Strength: 100/300/300 mg
  • Dosage Form: Tablet; oral
  • Company: Merck Sharp Dohme
  • Approval Date: August 30, 2018
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated  as a complete regimen for the treatment of HIV-1 infection in adult patients with no antiretroviral treatment history.  
  • Approved Label: 08/30/2018(PDF)
Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Infectious Diseases - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
Roshini Claire Anthony, 6 days ago

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.

Prof. Vincent Wong, Prof. Ray Kim, Dr. Tan Poh Seng, 10 Sep 2019
Chronic hepatitis B (CHB) remains a major public health concern because of its worldwide distribution and potential adverse sequelae, including cirrhosis and hepatocellular carcinoma (HCC). At a recent symposium held during the GIHep Singapore 2019, Professor Vincent Wong from the Chinese University of Hong Kong and Professor Ray Kim from the Stanford University School of Medicine, Stanford, California, US, discussed antiviral treatments for CHB, with a focus on the novel agent tenofovir alafenamide (Vemlidy®). Dr Tan Poh Seng from the National University Hospital, Singapore, chaired the symposium.
11 Sep 2019
Blood pressure (BP) in children is influenced by early-life exposure to several chemicals, built environment and meteorological factors, suggests a study.
Pearl Toh, 18 hours ago
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.