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Original New Drug Application Approvals by US FDA (16 - 31 August 2016)

31 Aug 2016
New drug applications approved by US FDA as of 16 - 31 August 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.

TROXYCA ER
  • Active Ingredient(s): Oxycodone hydrochloride; Naltrexone hydrochloride
  • Strength: 10MG/1.2MG; 20MG/2.4MG; 30MG/3.6MG; 40MG/4.8MG; 60MG/7.2MG; 80MG/9.6MG
  • Dosage Form: Oral capsule
  • Company: Pfizer Inc
  • Approval Date: August 19, 2016
  • Chemical Type: Not available
  • Indication(s): Indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
  • Approved Label: 08/19/2016 (PDF)

PALONOSETRON HYDROCHLORIDE
  • Active Ingredient(s): Palonosetron hydrochloride
  • Strength: 0.125 MG/ML
  • Dosage Form: Injectable; injection
  • Company: Exela Pharma SCS LLC
  • Approval Date: August 22, 2016
  • Chemical Type: 5  New formulation or new manufacturer
  • Indication(s): Indicated in adults for:
    • Moderately emetogenic cancer chemotherapy – prevention of acute and delayed nausea and vomiting associated with initial and repeat courses
    • Highly emetogenic cancer chemotherapy – prevention of acute nausea and vomiting associated with initial and repeat courses.
  • Approved Label: 08/22/2016 (PDF)

ERELZI
  • Active Ingredient(s): Etanercept-SZZS
  • Strength: 25MG/0.5ML; 50MG/ML
  • Dosage Form: Injectable; Injection
  • Company: Sandoz Inc
  • Approval Date: August 30, 2016
  • Chemical Type: Not available
  • Indication(s): Indicated for the treatment of:
    • Rheumatoid Arthritis (RA)
    • Polyarticular Juvenile Idiopathic Arthritis (JIA) in patients aged 2 years or older
    • Psoriatic Arthritis (PsA)
    • Ankylosing Spondylitis (AS)
    • Plaque Psoriasis (PsO)
  • Approved Label: 08/30/2016 (PDF)
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Most Read Articles
5 days ago
In patients with type 2 diabetes, obesity may be protective against vision-threatening diabetic retinopathy, a recent Korea study has shown.
Roshini Claire Anthony, 4 days ago

Men with metastatic hormone-sensitive prostate cancer (mHSPC) who receive testosterone suppression therapy may have a better survival outcome with the addition of enzalutamide over other non-steroidal anti-androgen (NSAA) therapies, according to the phase III ENZAMET* trial.

07 Jun 2019
Low-dose aspirin therapy does not confer significant benefits to elderly patients with hypertension, but treatment appears to increase the risk of haemorrhagic events, suggest a Japan study.
4 days ago
The use of opioids may have limited long-term efficacy in the management of chronic noncancer pain, reports a new study.