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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
6 days ago
Regular practice of yoga postures confers benefits for glucose control, oxidative stress, inflammatory response, and sleep quality in patients with type 2 diabetes, a study has found.
01 Dec 2020
Tetanus toxoid 5 Lf, diphtheria toxoid 2 Lf, pertussis toxoid 2.5 mcg, filamentous haemagglutinin 5 mcg, fimbriae types 2 and 3 5 mcg, pertactin 3 mcg
Dr. Hsu Li Yang, Dr. Tan Thuan Tong, Dr. Andrea Kwa, 08 Jan 2021
Antimicrobial resistance has become increasingly dire as the rapid emergence of drug resistance, especially gram-negative pathogens, has outpaced the development of new antibiotics. At a recent virtual symposium, Dr Hsu Li Yang, Vice Dean (Global Health) and Programme Leader (Infectious Diseases), NUS Saw Swee Hock School of Public Health, presented epidemiological data on multidrug-resistant (MDR) gram-negative bacteria (GNB) in Asia, while Dr Tan Thuan Tong, Head and Senior Consultant, Department of Infectious Diseases, Singapore General Hospital (SGH), focused on the role of ceftazidime-avibactam in MDR GNB infections. Dr Andrea Kwa, Assistant Director of Research, Department of Pharmacy, SGH, joined the panel in an interactive fireside chat, to discuss challenges, practical considerations, and solutions in MDR gram-negative infections. This Pfizer-sponsored symposium was chaired by Dr Ng Shin Yi, Head and Senior Consultant of Surgical Intensive Care, SGH.
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