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Pearl Toh, 31 Dec 2019
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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.
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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.
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Original New Drug Application Approvals by US FDA (1 - 15 July 2017)

28 Jul 2017
New drug applications approved by US FDA as of 1 - 15 July 2017 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.

OMEPRAZOLE
  • Active Ingredient(s): OMEPRAZOLE
  • Strength: 20MG
  • Dosage Form: Oral Disintegrating extended-release tablet
  • Company: Dexcel Pharma
  • Approval Date: July 5, 2017
  • Chemical Type: Type 8 - Partial Rx to OTC Switch
  • Indication(s): Indicated for the treatment of frequent heartburn (occurs 2 or more days a week)
  • Approved Label: 07/05/2017 (PDF)

ENDARI
  • Active Ingredient(s): L-GLUTAMINE
  • Strength: 5G
  • Dosage Form: Oral Powder
  • Company: Emmaus Medcl
  • Approval Date: July 7, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older
  • Approved Label: 07/07/2017 (PDF)

TREMFYA
  • Active Ingredient(s): GUSELKUMAB
  • Strength: 100MG/ML
  • Dosage Form: Injectable; Injection
  • Company: Janssen Biotech
  • Approval Date: July 13, 2017
  • Chemical Type: Not available
  • Indication(s): Indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
  • Approved Label: 07/13/2017 (PDF)

ZYPITAMAG
  • Active Ingredient(s): PITAVASTATIN
  • Strength: 1MG, 2MG, 4MG
  • Dosage Form: Oral Tablet
  • Company: Zydus Pharms USA Inc
  • Approval Date: July 14, 2017
  • Chemical Type: Type 2 - New Active Ingredient
  • Indication(s): Indicated for patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C)
  • Approved Label: 07/14/2017 (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.