Original New Drug Application Approvals by US FDA (16 - 31 May 2020)

New drug applications approved by US FDA as of 16 - 31 May 2020 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.

FERRIPROX

• Active Ingredient(s): Deferiprone
• Strength: 1,000 mg
• Dosage Form(s) / Route(s): Tablet; oral
• Company: Apopharma, Inc.
• Approval Date: 19 May 2020
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.
• Approved Label: 19 May 2020 (PDF)

IMPEKLO

• Active Ingredient(s): Clobetasol propionate
• Strength: 0.05% w/w
• Dosage Form(s) / Route(s): Lotion; topical
• Company: Mylan
• Approval Date: 19 May 2020
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older.
• Approved Label: 19 May 2020 (PDF)

KYNMOBI

• Active Ingredient(s): Apomorphine hydrochloride
• Strength: 10 mg; 15 mg; 20 mg; 25 mg; 30 mg
• Dosage Form(s) / Route(s): Film; sublingual
• Company: Sunovion Pharms, Inc.
• Approval Date: 21 May 2020
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for the acute, intermittent treatment of "off" episodes in patients with Parkinson's disease.
• Approved Label: 21 May 2020 (PDF)

CERIANNA

• Active Ingredient(s): Fluoroestradiol f18
• Strength: 148 MBq/mL to 3,700 MBq/mL (4 mCi/mL to 100 mCi/mL)
• Dosage Form(s) / Route(s): Injectable; injection
• Company: Zionexa US Corp
• Approval Date: 20 May 2020
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.
• Approved Label: 20 May 2020 (PDF)

PHEXXI

• Active Ingredient(s): Lactic acid; citric acid; potassium bitartrate
• Strength: 5 g
• Dosage Form(s) / Route(s): Gel; vaginal
• Company: Evofem, Inc.
• Approval Date: 22 May 2020
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.
• Approved Label: 22 May 2020 (PDF)

VESICARE LS

• Active Ingredient(s): Solifenacin succinate
• Strength: 5 mg/5 mL (1 mg/mL)
• Dosage Form(s) / Route(s): Suspension; oral
• Company: Astellas
• Approval Date: 26 May 2020
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for the treatment of neurogenic detrusor overactivity in pediatric patients aged 2 years and older.
• Approved Label: 26 May 2020 (PDF)

ARTESUNATE

• Active Ingredient(s): Artesunate
• Strength: 110 mg
• Dosage Form(s) / Route(s): Injectable; injection
• Company: Amivas, LLC
• Approval Date: 26 May 2020
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the initial treatment of severe malaria in adult and pediatric patients. Treatment of severe malaria with Artesunate for Injection should always be followed by a complete treatment course of an appropriate oral antimalarial regimen.
• Approved Label: 26 May 2020 (PDF)

TAUVID

• Active Ingredient(s): Flortaucipir f18
• Strength: 370 MBq (10 mCi)
• Dosage Form(s) / Route(s): Injectable; injection
• Company: Avid Radiopharms, Inc.
• Approval Date: 28 May 2020
• Submission Classification: Type 1 - New Molecular Entitiy
• Indication(s): Indicated for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease.
• Approved Label: 28 May 2020 (PDF)

ZILXI

• Active Ingredient(s): Minocycline
• Strength: 1.5%
• Dosage Form(s) / Route(s): Fiber, extended release; periodontal
• Company: Foamix
• Approval Date: 28 May 2020
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for the treatment of inflammatory lesions of rosacea in adults.
• Approved Label: 28 May 2020 (PDF)

ORIAHNN

• Active Ingredient(s): Elagolix; estradiol norethindrone acetate; elagolix
• Strength: 300 mg; 1 mg; 0.5 mg; 300 mg
• Dosage Form(s) / Route(s): Capsule; oral
• Company: Abbvie, Inc.
• Approval Date: 29 May 2020
• Submission Classification: Type 4 - New Combination
• Indication(s): Indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.
• Approved Label: 29 May 2020 (PDF)