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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)
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Most Read Articles
Roshini Claire Anthony, 5 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.

Stephen Padilla, 6 days ago
Implementation of the collaborative care in a rheumatoid arthritis (RA) clinic has led to improvements in nonbiologic disease-modifying antirheumatic drugs (nb-DMARDs) optimization, adherence to safety recommendations on nb-DMARD monitoring and detection of adverse drug events in RA patients, according to a Singapore study.
5 days ago
Blood pressure (BP) in children is influenced by early-life exposure to several chemicals, built environment and meteorological factors, suggests a study.
5 days ago
Short sleep duration is associated with an increased risk of myocardial infarction (MI), according to prospective observational and Mendelian randomization (MR) analyses.