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Elvira Manzano, 23 Nov 2016
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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
04 Jul 2016
Results of a study show that a single diagnosed chlamydia infection is linked with increased risk of reproductive complications including pelvic inflammatory disease, ectopic pregnancy, and tubal factor infertility.
Elvira Manzano, 23 Nov 2016
The US Food and Drug Administration (FDA) has approved tenofovir alafenamide (TAF), a nucleoside analog reverse transcriptase inhibitor, as a single agent for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.