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– 29 Feb 2016)

01 Mar 2016
New drug applications approved by US FDA as of 16 - 29 Feb 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.

BRIVIACT
  • Active Ingredient(s): Brivaracetam
  • Strength: 10MG, 25MG, 50MG, 75MG, 100MG
  • Dosage Form: Oral tablet
  • Company: UCB Inc
  • Approval Date: February 18, 2016
  • Chemical Type: 1  New molecular entity (NME)
  • Indication(s): Indicated as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy
  • Approved Label: 02/18/2016 (PDF)

BRIVIACT
  • Active Ingredient(s): Brivaracetam
  • Strength: 50MG/ML
  • Dosage Form: Injectable injection
  • Company: UCB Inc
  • Approval Date: February 18, 2016
  • Chemical Type: 1  New molecular entity (NME)
  • Indication(s): Indicated as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy
  • Approved Label: 02/18/2016 (PDF)

BRIVIACT
  • Active Ingredient(s): Brivaracetam
  • Strength: 10MG/ML
  • Dosage Form: Oral solution
  • Company: UCB Inc
  • Approval Date: February 18, 2016
  • Chemical Type: 1  New molecular entity (NME)
  • Indication(s): Indicated as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy
  • Approved Label: 02/18/2016 (PDF)

XELJANZ
  • Active Ingredient(s): Tofacitinib
  • Strength: 11MG
  • Dosage Form: Extended-release oral tablet
  • Company: Pfizer Inc
  • Approval Date: February 23, 2016
  • Chemical Type: 3  New dosage form
  • Indication(s): Indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response orintolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).
  • Approved Label: 02/23/2016 (PDF)

ACZONE
  • Active Ingredient(s): Dapsone
  • Strength: 7.5%
  • Dosage Form: Topical gel
  • Company: Allergan
  • Approval Date: February 24, 2016
  • Chemical Type: 5  New formulation or new manufacturer
  • Indication(s): Indicated for the topical treatment of acne vulgaris in patients 12 years of age and older
  • Approved Label: 02/24/2016 (PDF)

TETRACAINE HYDROCHLORIDE
  • Active Ingredient(s): Tetracaine hydrochloride
  • Strength: 0.5%
  • Dosage Form: Ophthalmic solution
  • Company: Alcon Res Ltd
  • Approval Date: February 29, 2016
  • Chemical Type: 7  Drug already marketed without an approved NDA
  • Indication(s): Not available
  • Approved Label: Not available

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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.