Original New Drug Application Approvals by US FDA (16 - 31 August 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 Label: 16 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 Label: 16 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 Label: 19 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 Label: 19 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 Label: 19 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 Label: 21 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 Label: 27 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 Label: 28 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 Label: 28 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 Label: 29 August 2019 (PDF)