Most Read Articles
Rachel Soon, 22 Mar 2019

At the recent forum “Improving Access to Affordable Cancer Treatments in Malaysia”, the issue of treatment costs was discussed by panellists from the Ministry of Health (MOH) and pharmaceutical industry representatives.

18 Mar 2019
Aspirin use is associated with a lower risk of glioma, according to data from the Glioma International Case-Control Study.
11 Apr 2019
Overall, 5-fluorouracil is more effective than imiquimod in reducing the risk of keratinocyte carcinoma, but there are no differences in the short- or long-term risk of subsequent site-specific keratinocyte carcinoma in a real-world practice setting, according to a new study.
18 Feb 2019
Supplementation with folic acid and vitamin B12 potentially contributes to an increased risk of colorectal cancer, according to data from the B Vitamins for the Prevention of Osteoporotic Fractures (B-PROOF) trial.

Original New Drug Application Approvals by US FDA (01 - 15 March 2019)

15 Mar 2019
New drug applications approved by US FDA as of 01 - 15 March 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.

SPRAVATO
  • Active Ingredient(s): Esketamine
  • Strength: 56 mg; 84 mg
  • Dosage Form(s) / Route(s): Spray; Nasal
  • Company: Janssen Pharms
  • Approval Date: 05 Mar 2019
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression (TRD) in adults.
  • Approved Label05 Mar 2019 (PDF)

TRAZIMERA
  • Active Ingredient(s): Trastuzumab-qyyp
  • Strength: 420 mg
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Pfizer Inc
  • Approval Date: 11 Mar 2019
  • Submission Classification: Not Available
  • Indication(s): Indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression (TRD) in adults.
    • The treatment of HER2-overexpressing breast cancer.
    • The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
  • Approved Label11 Mar 2019 (PDF)

ROCKLATAN
  • Active Ingredient(s): Netarsudil; Latanoprost
  • Strength: 0.02%; 0.005%
  • Dosage Form(s) / Route(s): Solution; Ophthalmic
  • Company: Aerie Pharms Inc
  • Approval Date: 12 Mar 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
  • Approved Label: 12 Mar 2019 (PDF)

TETRACAINE HYDROCHLORIDE
  • Active Ingredient(s): Tetracaine hydrochloride
  • Strength: 5%
  • Dosage Form(s) / Route(s): Solution; Ophthalmic
  • Company: Paragon Bioteck
  • Approval Date: 12 Mar 2019
  • Submission Classification:
  • Indication(s): Indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.
  • Approved Label: 12 Mar 2019 (PDF)
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Most Read Articles
Rachel Soon, 22 Mar 2019

At the recent forum “Improving Access to Affordable Cancer Treatments in Malaysia”, the issue of treatment costs was discussed by panellists from the Ministry of Health (MOH) and pharmaceutical industry representatives.

18 Mar 2019
Aspirin use is associated with a lower risk of glioma, according to data from the Glioma International Case-Control Study.
11 Apr 2019
Overall, 5-fluorouracil is more effective than imiquimod in reducing the risk of keratinocyte carcinoma, but there are no differences in the short- or long-term risk of subsequent site-specific keratinocyte carcinoma in a real-world practice setting, according to a new study.
18 Feb 2019
Supplementation with folic acid and vitamin B12 potentially contributes to an increased risk of colorectal cancer, according to data from the B Vitamins for the Prevention of Osteoporotic Fractures (B-PROOF) trial.