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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)
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Most Read Articles
Pearl Toh, 31 Dec 2019
Adding the neuraminidase inhibitor oseltamivir to usual care speeds up recovery from influenza-like illness by a day compared with usual care alone, with even greater benefits seen in older, sicker patients with comorbidities, according to the ALIC4E study.
09 Jan 2020
Acute ischaemic stroke patients who are current or recent smokers are at greater odds of having unfavourable functional outcomes 3 months after the index event, a study has found.
Stephen Padilla, 2 days ago
Brodalumab has exhibited long-term efficacy and consistent safety profile for more than 2 years in the treatment of patients with psoriasis, results of the phase III AMAGINE-2 trial show.
2 days ago
Anaemia increases mortality risk in heart failure (HF) patients across the ejection fraction (EF) spectrum, a recent study has found. The effect appears to be stronger in preserved (HFpEF) and midrange (HFmrEF) than in reduced (HFrEF) EF disease.