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Long-term treatment with the interleukin-5 receptor alpha-directed cytolytic monoclonal antibody benralizumab led to long-term control of asthma, improvement in pulmonary function, and was safe in patients with severe eosinophilic asthma in the 2-year integrated analysis of the SIROCCO, CALIMA, and ZONDA pivotal studies plus the BORA extension study reported at ATS 2019.

Original New Drug Application Approvals by US FDA (1 - 15 August 2018)

15 Aug 2018

New drug applications approved by US FDA as of 01-15 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.

TIGECYCLINE

  • Active Ingredient(s): Tigecycline
  • Strength: 50 mg
  • Dosage Form: Injectable;injection
  • Company: Amneal Pharms LLC
  • Approval Date: August 02, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated  in patients 18 years of age and older for:
    • Complicated skin and skin structure infections.
    • Complicated intra-abdominal infections.
    • Community-acquired bacterial pneumonia.
  • Approved Label: 08/02/2018(PDF)
ORKAMBI
  • Active Ingredient(s): Lumacaftor; Ivacaftor
  • Strength: 100 mg; 125 mg
  • Dosage Form: Granule; oral
  • Company: Vertex Pharms
  • Approval Date: August 07, 2018
  • Submission Classification:  Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of cystic fibrosis (CF) in patients age 2 years and older who are homozygous for the F508del mutation in the CFTR gene. If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene.
  • Approved Label: 08/07/2018(PDF)
SOLUPREP
  • Active Ingredient(s): 2%Chlorhexidine Gluconate; 70% Isopropyl Alcohol 
  • Strength: 2%;70%
  • Dosage Form: Injectable; injection
  • Company: 3M
  • Approval Date: August 08, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for use as a patient preoperative skin preparation, for preparation of the skin prior to surgery, and to help reduce bacteria that can potentially cause skin infection.
  • Approved Label: 08/082018(PDF)
JORNAY PM
  • Active Ingredient(s): Methylphenidate Hydrochloride
  • Strength: 20 mg; 40 mg; 60 mg; 80 mg;100 mg
  • Dosage Form: Tablet, Extended Release; oral
  • Company: Ironshore Pharma Dev Inc
  • Approval Date: August 08, 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. 
  • Approved Label: 08/08/2018(PDF)
ARAKODA
  • Active Ingredient(s): Tafenoquine
  • Strength: 100 mg
  • Dosage Form: Tablet; oral
  • Company: 60 Degrees Pharms LLC
  • Approval Date: August 08, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the prophylaxis of malaria in patients aged 18 years and older. 
  • Approved Label: 08/08/2018(PDF)
POTELIGEO
  • Active Ingredient(s): Mogamulizumab-KPKC
  • Strength: 20 mg/5 ml
  • Dosage Form: Injectable; injection
  • Company: Kyowa Kirin
  • Approval Date: August 08, 2018
  • Submission Classification: not applicable
  • Indication(s): Indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy
  • Approved Label: 08/08/2018(PDF)
GALAFOLD
  • Active Ingredient(s): Migalastat hydrochloride
  • Strength: 150 mg
  • Dosage Form: Capsule; oral
  • Company: Amicus Therapeutics US Inc
  • Approval Date: August 10, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for   the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data. 
  • Approved Label: 08/10/2018(PDF)
ANNOVERA
  • Active Ingredient(s): Segesterone Acetate; Ethinyl Estradiol
  • Strength: 0.15 mg; 0.013 mg/day
  • Dosage Form: Solution/drops; otic
  • Company: The Population Council Inc
  • Approval Date: August 10, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for use by females of reproductive potential to prevent pregnancy. 
  • Approved Label: 08/10/2018(PDF)
ONPATTRO
  • Active Ingredient(s): Patisiran
  • Strength: 2 mg/ml
  • Dosage Form: Injectable; injection
  • Company: Alnylam Pharma Inc
  • Approval Date: August 10, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
  • Approved Label: 08/10/2018(PDF)
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE
  • Active Ingredient(s): Lamivudine; Nevirapine; Zidovudine
  • Strength: 150 mg; 200 mg; 300 mg
  • Dosage Form: Tablet; oral
  • Company: Micro Labs Ltd
  • Approval Date: August 13, 2018
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated  alone as a complete regimen or in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg.
  • Approved Label: 08/13/2018(PDF)
CEQUA
  • Active Ingredient(s): Cyclosporine
  • Strength: 0.09%
  • Dosage Form: Solution; Ophthalmic
  • Company: Sun Pharma Global
  • Approval Date: August 14, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye)
  • Approved Label: 08/14/2018(PDF)
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
  • Active Ingredient(s): Efavirenz; Lamivudine; Tenofor Disoproxil Fumarate
  • Strength: 600 mg; 300 mg; 300 mg
  • Dosage Form: Tablet; oral
  • Company: Aurobindo Pharma Ltd
  • Approval Date: August 15, 2018
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Not applicable
  • Approved Label: Not applicable
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Most Read Articles
18 Jun 2019
The aromatase inhibitor anastrozole shows promise in the treatment of children with congenital adrenal hyperplasia, reducing bone age advancement without adversely affecting bone mineral density and visceral adipose tissue, as shown in a recent study.
6 days ago
The choice between nonvitamin K antagonist oral anticoagulants (NOACs) or vitamin K antagonists (VKAs) for stroke prevention appears to be complex and largely heterogenous across different, countries, a new study has found.
Yesterday
Monotherapy with tenofovir disoproxil fumarate increases virologic response for up to 240 weeks in pretreated patients with hepatitis B virus infection (HBV) who are resistant to entecavir and/or adefovir, a new study has found.
Elvira Manzano, Yesterday
Long-term treatment with the interleukin-5 receptor alpha-directed cytolytic monoclonal antibody benralizumab led to long-term control of asthma, improvement in pulmonary function, and was safe in patients with severe eosinophilic asthma in the 2-year integrated analysis of the SIROCCO, CALIMA, and ZONDA pivotal studies plus the BORA extension study reported at ATS 2019.