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

New drug applications approved by US FDA as of 01 - 15 October 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.

HEMADY

• Active Ingredient(s): Dexamethasone
• Strength: 20 mg
• Dosage Form(s) / Route(s): Tablet; oral
• Company: Dexcel Pharma
• Approval Date: 03 October 2019
• Submission Classification: Not available
• Indication(s): Indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma.
• Approved Label: 03 October 2019 (PDF)

AKLIEF

• Active Ingredient(s): Trifarotene
• Strength: 0.005%
• Dosage Form(s) / Route(s): Cream; topical
• Company: Galderma Research and Dev, Inc.
• Approval Date: 04 October 2019
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the topical treatment of acne vulgaris in patient 9 year of age and older.
• Approved Label: 04 October 2019 (PDF)

BORTEZOMIB

• Active Ingredient(s): Bortezomib
• Strength: 3.5 mg
• Dosage Form(s) / Route(s): Injectable; injection
• Company: Dr. Reddy's Labs, Inc.
• Approval Date: 04 October 2019
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for:
• treatment of adult patients with multiple myeloma.
• treatment of adult patients with mantle cell lymphoma who have received at least 1 prior therapy.
• Approved Label: 04 October 2019 (PDF)

QUZYTTIR

• Active Ingredient(s): Cetirizine hydrochloride
• Strength: 10 mg/mL
• Dosage Form(s) / Route(s): Injectable; injection
• Company: JDP Therapeutics, Inc.
• Approval Date: 04 October 2019
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for the treatment of acute urticaria in adults and children 6 months of age and older.
• Approved Label: 04 October 2019 (PDF)

BONSITY

• Active Ingredient(s): Teriparatide
• Strength: 20 mcg
• Dosage Form(s) / Route(s): Injectable; injection
• Company: Pfenex, Inc.
• Approval Date: 04 October 2019
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for:
• Treatment of postmenopausal women with osteoporosis at high risk for fracture.
• Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture.
• Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.
• Approved Label: 04 October 2019 (PDF)

BEOVU

• Active Ingredient(s): Brolucizumab-dbll
• Strength: 6 mg/0.5 mL
• Dosage Form(s) / Route(s): Injectable; intravitreal
• Company: Novartis Pharms Corp.
• Approval Date: 07 October 2019
• Submission Classification: Not available
• Indication(s): Indicated for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (AMD).
• Approved Label: 07 October 2019 (PDF)

SCENESSE

• Active Ingredient(s): Afamelanotide
• Strength: 16 mg
• Dosage Form(s) / Route(s): Implant; subcutaneous
• Company: Clinuvel, Inc.
• Approval Date: 08 October 2019
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).
• Approved Label: 08 October 2019 (PDF)

FLUORODEOXYPHENYLALANINE ([18F]-DOPA)

• Active Ingredient(s): Fluorodeoxyphenylalanine
• Strength: 185 MBq
• Dosage Form(s) / Route(s): Injectable; injection
• Company: Feinstein
• Approval Date: 10 October 2019
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes (PS). Fluorodopa F 18 PET is an adjunct to other diagnostic evaluations.
• Approved Label: 10 October 2019 (PDF)

REYVOW

• Active Ingredient(s): Lasmiditan succinate
• Strength: 50 mg; 100 mg
• Dosage Form(s) / Route(s): Tablet; oral
• Company: Eli Lilly and Co.
• Approval Date: 11 October 2019
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the acute treatment of migraine with or without aura in adults.
• Approved Label: 11 October 2019 (PDF)

SECUADO

• Active Ingredient(s): Asenapine
• Strength: 3.8 mg; 5.7 mg; 7.6 mg
• Dosage Form(s) / Route(s): System; transdermal
• Company: Hisamitsu Pharm, Co.
• Approval Date: 11 October 2019
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Not available
• Approved Label: Not available