Most Read Articles
Roshini Claire Anthony, 3 days ago

Individuals with moderate-to-severe plaque psoriasis may reap better long-term improvements in the severity of their condition when treated with guselkumab over secukinumab, according to findings of the phase III ECLIPSE* trial presented at the recent Inflammatory Skin Disease Summit (ISDS 2018) held in Vienna, Austria.

Jairia Dela Cruz, 11 Jan 2019
Use of standard-dose aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) appears to confer protection against the risk of endometrial cancer in overweight and obese women, according to a meta-analysis.
Elvira Manzano, 4 days ago
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2 days ago
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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
Roshini Claire Anthony, 3 days ago

Individuals with moderate-to-severe plaque psoriasis may reap better long-term improvements in the severity of their condition when treated with guselkumab over secukinumab, according to findings of the phase III ECLIPSE* trial presented at the recent Inflammatory Skin Disease Summit (ISDS 2018) held in Vienna, Austria.

Jairia Dela Cruz, 11 Jan 2019
Use of standard-dose aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) appears to confer protection against the risk of endometrial cancer in overweight and obese women, according to a meta-analysis.
Elvira Manzano, 4 days ago
Treatment with two investigational, oral JAK inhibitors may be beneficial in individuals with moderate‐to‐severe alopecia areata (spot baldness), an autoimmune disease that can cause a lot of anxiety, according to an ongoing phase II study.
2 days ago
Discontinuing the use of tyrosine kinase inhibitors (TKIs) in the treatment of patients with chronic myeloid leukaemia appears to be feasible in real-life clinical practice in the context of close molecular monitoring, a study reports.