Most Read Articles
Jairia Dela Cruz, 31 Oct 2018
The question of whether to exercise or not typically emerges in the setting of chronic pain, as patients fear that moving may contribute to exacerbate their condition. Yet, exercise does exert hypoalgesic effects on chronic pain conditions however variable these effects are, according to a senior physiotherapist who spoke at the Singapore Health & Biomedical Congress 2018.
01 Dec 2015
Adding tofacitinib to treatment strategy decreases cost and improves quality-adjusted life-years in patients with moderate to severe rheumatoid arthritis (RA), as observed in a Canadian cost-effectiveness analysis.
21 Oct 2018
Individuals with increased femoral neck body mineral density (BMD) are highly likely to develop subsequent radiographic osteoarthritis of the knee and hip but not of the hand, a study suggests.
Audrey Abella, 16 Oct 2018
Individuals with diabetes have a higher risk of osteoarthritis, rheumatoid arthritis (RA), and osteoporosis, according to a Danish study presented at EASD 2018.

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)
Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Rheumatology digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
Jairia Dela Cruz, 31 Oct 2018
The question of whether to exercise or not typically emerges in the setting of chronic pain, as patients fear that moving may contribute to exacerbate their condition. Yet, exercise does exert hypoalgesic effects on chronic pain conditions however variable these effects are, according to a senior physiotherapist who spoke at the Singapore Health & Biomedical Congress 2018.
01 Dec 2015
Adding tofacitinib to treatment strategy decreases cost and improves quality-adjusted life-years in patients with moderate to severe rheumatoid arthritis (RA), as observed in a Canadian cost-effectiveness analysis.
21 Oct 2018
Individuals with increased femoral neck body mineral density (BMD) are highly likely to develop subsequent radiographic osteoarthritis of the knee and hip but not of the hand, a study suggests.
Audrey Abella, 16 Oct 2018
Individuals with diabetes have a higher risk of osteoarthritis, rheumatoid arthritis (RA), and osteoporosis, according to a Danish study presented at EASD 2018.