Most Read Articles
Jairia Dela Cruz, 18 Dec 2018
The use of ixekizumab to selectively target interleukin-17A (IL-17A) in disease-modifying antirheumatic drug-naïve patients with ankylosing spondylitis yields improvements in disease activity, health-related quality of life, day-to-day physical activity, and bone marrow oedema of the spine and sacroiliac joint, according to the results of the phase III COAST-V study.
10 Jan 2019
Only a few sonographic enthesitis scoring instruments developed for spondyloarthritis (SpA) have been validated in psoriatic arthritis (PsA), and none of them passed the Outcome Measures in Rheumatology (OMERACT) filter in patients with PsA, according to a systematic review.

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, 18 Dec 2018
The use of ixekizumab to selectively target interleukin-17A (IL-17A) in disease-modifying antirheumatic drug-naïve patients with ankylosing spondylitis yields improvements in disease activity, health-related quality of life, day-to-day physical activity, and bone marrow oedema of the spine and sacroiliac joint, according to the results of the phase III COAST-V study.
10 Jan 2019
Only a few sonographic enthesitis scoring instruments developed for spondyloarthritis (SpA) have been validated in psoriatic arthritis (PsA), and none of them passed the Outcome Measures in Rheumatology (OMERACT) filter in patients with PsA, according to a systematic review.