Most Read Articles
29 Nov 2019
Metformin Extended Release 500 mg,750 mg, and 1000 mg
Pearl Toh, 2 days ago
Getting just under one extra hour of sleep per night can go a long way for the health of college students, who are often sleep-deprived, a study suggests.
29 Nov 2019
Saxagliptin 5 mg, dapagliflozin 10 mg FC tab
Roshini Claire Anthony, 6 days ago

The CA125* test could be useful at detecting ovarian cancer and various other cancers in the primary care setting, particularly for women aged >50 years, according to a study presented at the recent NCRI** Cancer Conference held in Glasgow, Scotland, UK.

Original New Drug Application Approvals by US FDA (16 - 31 October 2019)

31 Oct 2019
New drug application approved by US FDA as of 16 - 31 October 2019 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.

AMZEEQ
  • Active Ingredient(s): Minocycline
  • Strength: 4%
  • Dosage Form(s) / Route(s):Aerosol, foam; topical
  • Company: Foamix Pharma, Inc.
  • Approval Date: 18 October 2019
  • Submission Classification: Not available
  • Indication(s): Indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
  • Approved Label18 October 2019 (PDF)

TRIKAFTA
  • Active Ingredient(s): Elexacaftor, tezacaftor, ivacaftor; ivacaftor
  • Strength: 100 mg, 75 mg, 50 mg; 150 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Vertex Pharms, Inc.
  • Approval Date: 21 October 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the CFTR gene. If the patients's genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one F508del mutation.
  • Approved Label21 October 2019 (PDF)

BIORPHEN
  • Active Ingredient(s): Phenylephrine hydrochloride
  • Strength: 0.1 mg/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Sintetica SA
  • Approval Date: 21 October 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
  • Approved Label21 October 2019 (PDF)

VUMERITY
  • Active Ingredient(s): Diroximel fumarate
  • Strength: 231 mg
  • Dosage Form(s) / Route(s): Capsule, delayed release; oral
  • Company: Alkermes
  • Approval Date: 29 October 2019
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. 
  • Approved Label29 October 2019 (PDF)
Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Doctor - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
29 Nov 2019
Metformin Extended Release 500 mg,750 mg, and 1000 mg
Pearl Toh, 2 days ago
Getting just under one extra hour of sleep per night can go a long way for the health of college students, who are often sleep-deprived, a study suggests.
29 Nov 2019
Saxagliptin 5 mg, dapagliflozin 10 mg FC tab
Roshini Claire Anthony, 6 days ago

The CA125* test could be useful at detecting ovarian cancer and various other cancers in the primary care setting, particularly for women aged >50 years, according to a study presented at the recent NCRI** Cancer Conference held in Glasgow, Scotland, UK.