Most Read Articles
6 days ago
New drug applications approved by US FDA as of 01 - 15 November 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. 
14 Nov 2019
Streptococcus anginosus, aminoglycoside-susceptible Gram-negative bacilli and anaerobes remain the most common bacteria in previously healthy children presenting with complicated appendicitis requiring surgical drainage, reports a study.

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

03 Sep 2019
New drug applications approved by US FDA as of 16 - 31 August 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.

RINVOQ
  • Active Ingredient(s): Upadacitinib
  • Strength: 15 mg
  • Dosage Form(s) / Route(s): Tablet, extended release; oral
  • Company: Abbvie, Inc.
  • Approval Date: 16 August 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
  • Approved Label16 August 2019 (PDF)

INREBIC
  • Active Ingredient(s): Fedratinib hydrochloride
  • Strength: 400 mg 
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Impact Biomedicines, Inc.
  • Approval Date: 16 August 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).
  • Approved Label16 August 2019 (PDF)

HELIUM, USP
  • Active Ingredient(s): Helium
  • Strength: Not available
  • Dosage Form(s) / Route(s): Gas; inhalation
  • Company: AGL Welding Supply Co., Inc.
  • Approval Date: 18 August 2019
  • Submission Classification: Medical Gas
  • Indication(s): Not available
  • Approved Label: Not available

FULVESTRANT
  • Active Ingredient(s): Fulvestrant
  • Strength: 250 mg/5 mL (50 mg/mL)
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Teva Pharms USA, Inc.
  • Approval Date: 19 August 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of:
    • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.
    • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
    • HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy.
    • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.
  • Approved Label19 August 2019 (PDF)

XENLETA
  • Active Ingredient(s): Lefamulin acetate
  • Strength: 600 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Nabriva Therapeutics US, Inc.
  • Approval Date: 19 August 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms.
  • Approved Label19 August 2019 (PDF)

XENLETA
  • Active Ingredient(s): Lefamulin acetate
  • Strength: 150 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Nabriva Therapeutics US, Inc.
  • Approval Date: 19 August 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms.
  • Approved Label19 August 2019 (PDF)

Ga 68 DOTATOC
  • Active Ingredient(s): Ga 68 dotatoc
  • Strength: 18.5 - 148 MBq (0.5 - 4.0 mCi/mL)
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: University of Iowa Hospitals and Clinics Pet Imaging Center
  • Approval Date: 21 August 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for use with positron tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. 
  • Approved Label21 August 2019 (PDF)

NOURIANZ
  • Active Ingredient(s): Istradefylline
  • Strength: 20 mg; 40 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Kyowa Kirin Inc.
  • Approval Date: 27 August 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing "off" episodes.
  • Approved Label27 August 2019 (PDF)

HARVONI
  • Active Ingredient(s): Ledipasvir; sofosbuvir
  • Strength: 33.75 mg/150 mg; 45 mg/200 mg
  • Dosage Form(s) / Route(s): Pellets; oral
  • Company: Gilead Sciences, Inc.
  • Approval Date: 28 August 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of chronic hepatitis C virus (HCV) in adults and pediatric patients 3 years of age and older:
    • Genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
    • Genotype 1 infection with decompensated cirrhosis, in combination with ribavirin
    • Genotype 1 and 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with ribavirin.
  • Approved Label28 August 2019 (PDF)

SOVALDI
  • Active Ingredient(s): Sofosbuvir
  • Strength: 150 mg; 200 mg
  • Dosage Form(s) / Route(s): Pellets; oral
  • Company: Gilead Sciences, Inc.
  • Approval Date: 28 August 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of:
    • Adult patients with genotype 1, 2, 3, 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen.
    • Pediatric patients 3 years f age and older with genotype 2 or 3 chronic HCV infection without cirrhosis or with compensated cirrhosis in combination with ribavirin.
  • Approved Label28 August 2019 (PDF)

RIOMET ER
  • Active Ingredient(s): Metformin hydrochloride
  • Strength: 500mg/5mL
  • Dosage Form(s) / Route(s): Suspension, extended release; oral
  • Company: Sun Pharm Inds. Ltd. 
  • Approval Date: 29 August 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patient 10 years of age and older with type 2 diabetes mellitus.
  • Approved Label29 August 2019 (PDF)

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Most Read Articles
6 days ago
New drug applications approved by US FDA as of 01 - 15 November 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. 
14 Nov 2019
Streptococcus anginosus, aminoglycoside-susceptible Gram-negative bacilli and anaerobes remain the most common bacteria in previously healthy children presenting with complicated appendicitis requiring surgical drainage, reports a study.