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New Drug Approvals Archive - May 2020

See also: New Indications and Dosage Forms for May 2020

May 2020

Darzalex Faspro (daratumumab and hyaluronidase-fihj) Injection

Date of Approval: May 1, 2020
Company: The Janssen Pharmaceutical Companies of Johnson & Johnson
Treatment for: Multiple Myeloma; Light Chain (AL) Amyloidosis

Darzalex Faspro (daratumumab and hyaluronidase-fihj) is a combination of daratumumab (a CD38-directed cytolytic antibody) and hyaluronidase (an endoglycosidase) indicated for the treatment of multiple myeloma and light chain (AL) amyloidosis.

Fensolvi (leuprolide acetate) Injection

Date of Approval: May 1, 2020
Company: Tolmar Pharmaceuticals, Inc.
Treatment for: Precocious Puberty

Fensolvi (leuprolide acetate) is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty.

Elyxyb (celecoxib) Oral Solution

Date of Approval: May 5, 2020
Company: Dr. Reddy’s Laboratories Limited
Treatment for: Migraine

Elyxyb (celecoxib) is an oral solution formulation of the nonsteroidal anti-inflammatory drug celecoxib (first approved under the brand name Celebrex) indicated for the acute treatment of migraine with or without aura in adults.

Tabrecta (capmatinib) Tablets

Date of Approval: May 6, 2020
Company: Novartis
Treatment for: Non-Small Cell Lung Cancer

Tabrecta (capmatinib) is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.

Retevmo (selpercatinib) Capsules

Date of Approval: May 8, 2020
Company: Eli Lilly and Company
Treatment for: Non-Small Cell Lung Cancer, Thyroid Cancer

Retevmo (selpercatinib) is a kinase inhibitor for the treatment of patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer.

Qinlock (ripretinib) Tablets

Date of Approval: May 15, 2020
Company: Deciphera Pharmaceuticals, Inc.
Treatment for: Gastrointestinal Stromal Tumor

Qinlock (ripretinib) is a broad-spectrum KIT and PDGFRα inhibitor for the treatment of patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

Kynmobi (apomorphine hydrochloride) Sublingual Film

Date of Approval: May 21, 2020
Company: Sunovion Pharmaceuticals Inc.
Treatment for: Parkinson's Disease

Kynmobi (apomorphine sublingual film) is a novel formulation of the approved dopamine agonist apomorphine for the on-demand management of OFF episodes associated with Parkinson’s disease (PD).

Phexxi (lactic acid, citric acid and potassium bitartrate) Vaginal Gel - formerly Amphora

Date of Approval: May 22, 2020
Company: Evofem, Inc.
Treatment for: Birth Control

Phexxi (lactic acid, citric acid and potassium bitartrate) is a non-hormonal vaginal gel indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.

Cerianna (fluoroestradiol F18) Injection

Date of Approval: May 20, 2020
Company: Zionexa USA
Treatment for: Diagnosis and Investigation

Cerianna (fluoroestradiol F18) is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.

(artesunate) for Injection

Date of Approval: May 26, 2020
Company: Amivas (US), LLC
Treatment for: Malaria

Artesunate for Injection is an antimalarial indicated for the initial treatment of severe malaria in adult and pediatric patients.

Tauvid (flortaucipir F 18) Injection

Date of Approval: May 28, 2020
Company: Eli Lilly and Company
Treatment for: Diagnosis and Investigation

Tauvid (flortaucipir F 18) is a radioactive diagnostic agent 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 (AD).

Zilxi (minocycline) Topical Foam - formerly FMX103

Date of Approval: May 28, 2020
Company: Foamix Pharmaceuticals Ltd.
Treatment for: Rosacea

Zilxi (minocycline) is a topical tetracycline formulation indicated for the treatment of inflammatory lesions of rosacea in adults.

Oriahnn (elagolix/estradiol/norethindrone acetate and elagolix) Capsules

Date of Approval: May 29, 2020
Company: AbbVie Inc.
Treatment for: Uterine Leiomyomata

Oriahnn (elagolix/estradiol/norethindrone acetate and elagolix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist, estrogen and progestin co-formulation indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

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