Most Read Articles
01 Sep 2018

Gangliosides and docosahexaenoic acid (DHA) play critical roles in early childhood brain development. 

30 Nov 2017
Gestational diabetes was positively associated with cardiovascular disease (CVD) later in life, according to a new study. Adhering to a healthy lifestyle may, however, offset this risk.
Pearl Toh, 06 Apr 2016
Women have more cardiac risk factors than men, yet are more likely to be categorized as being at lower risk based on standard scoring test for cardiovascular risk, according to the PROMISE* study presented at the 65th American College of Cardiology (ACC) meeting. This highlights the need for sex-specific approaches to the diagnosis of heart disease.

Original New Drug Application Approvals by US FDA (16 - 30 September 2016)

30 Sep 2016
New drug applications approved by US FDA as of 16 - 30 September 2016 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.

KYLEENA
  • Active Ingredient(s): LEVONORGESTREL
  • Strength: 19.5MG
  • Dosage Form: System; Releasing Intrauterine
  • Company: Bayer Healthcare Pharms
  • Approval Date: September 16, 2016
  • Chemical Type: 5 New formulation or new manufacturer
  • Indication(s): Indicated for prevention of pregnancy for up to 5 years
  • Approved Label: 09/16/2016 (PDF)

EXONDYS 51
  • Active Ingredient(s): ETEPLIRSEN
  • Strength: 100MG/2ML ; 500MG/10ML
  • Dosage Form: Injectable; Injection
  • Company: Sarepta Therapeutics Inc.
  • Approval Date: September 19, 2016
  • Chemical Type: 1 New molecular entity (NME)
  • Indication(s): Indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping
  • Approved Label: 09/19/2016 (PDF)

INVOKAMET XR
  • Active Ingredient(s): CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE
  • Strength: 50MG/500MG ; 150MG/500MG ; 50MG/1000MG ; 150 MG/1000MG
  • Dosage Form: Tablet, Extended release; Oral
  • Company: Janssen Pharms
  • Approval Date: September 20, 2016
  • Chemical Type: 4 New combination
  • Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both canagliflozin and metformin is appropriate
  • Approved Label: 09/20/2016 (PDF)

EPANED
  • Active Ingredient(s): ENALAPRIL MALEATE
  • Strength: 1MG/ML
  • Dosage Form: Solution; Oral
  • Company: Silvergate Pharms
  • Approval Date: September 20, 2016
  • Chemical Type: 5 New formulation or new manufacturer
  • Indication(s): Indicated for:
    • Treatment of hypertension in adults and children older than one month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction
    • Treatment of symptomatic heart failure
    • Treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure
  • Approved Label: 09/20/2016 (PDF)

AMJEVITA
  • Active Ingredient(s): ADALIMUMAB-ATTO
  • Strength: 20MG/0.4ML ; 40MG/0.8ML
  • Dosage Form: Injectable; Injection
  • Company: Amgen Inc
  • Approval Date: September 23, 2016
  • Chemical Type: Not available
  • Indication(s): Indicated for treatment of: 
    • Rheumatoid Arthritis (RA): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA
    • Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 4 years of age and older
    • Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA
    • Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS
    • Adult Crohn’s Disease (CD): Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab
    • Ulcerative Colitis (UC): Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers
    • Plaque Psoriasis (Ps): The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemictherapy or phototherapy, and when other systemic therapies are medically less appropriate
  • Approved Label: 09/23/2016 (PDF)

STELARA
  • Active Ingredient(s): USTEKINUMAB
  • Strength: 130MG/26ML
  • Dosage Form: Injectable; Injection
  • Company: Janssen Biotech
  • Approval Date: September 23, 2016
  • Chemical Type: 3 New dosage form
  • Indication(s): Indicated for the treatment of adult patients with:
    • Moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy
    • Active psoriatic arthritis (PsA), alone or in combination with methotrexate
    • Moderately to severely active Crohn’s disease (CD) who have
      • failed or were intolerant to treatment with immunomodulators orcorticosteroids, but never failed a tumor necrosis factor (TNF) blocker or
      • failed or were intolerant to treatment with one or more TNF blockers.
  • Approved Label: 09/23/2016 (PDF)

LEVOLEUCOVORIN
  • Active Ingredient(s): LEVOLEUCOVORIN CALCIUM
  • Strength: 175MG
  • Dosage Form: Injectable; Injection
  • Company: Actavis LLC
  • Approval Date: September 29, 2016
  • Chemical Type: 5  New formulation or new manufacturer
  • Indication(s): Indicated for:
    • Rescue after high-dose methotrexate therapy in osteosarcoma
    • Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination
  • Approved Label: 09/29/2016 (PDF)

RUBY-FILL
  • Active Ingredient(s): RUBIDIUM RB-82 CHLORIDE
  • Strength: 2220MBQ
  • Dosage Form: Injectable; Injection
  • Company: Jubilant Draximage
  • Approval Date: September 30, 2016
  • Chemical Type: 5  New formulation or new manufacturer
  • Indication(s): Not available
  • Approved Label: Not available
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Most Read Articles
01 Sep 2018

Gangliosides and docosahexaenoic acid (DHA) play critical roles in early childhood brain development. 

30 Nov 2017
Gestational diabetes was positively associated with cardiovascular disease (CVD) later in life, according to a new study. Adhering to a healthy lifestyle may, however, offset this risk.
Pearl Toh, 06 Apr 2016
Women have more cardiac risk factors than men, yet are more likely to be categorized as being at lower risk based on standard scoring test for cardiovascular risk, according to the PROMISE* study presented at the 65th American College of Cardiology (ACC) meeting. This highlights the need for sex-specific approaches to the diagnosis of heart disease.