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