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New Drug Approvals Archive - August 2020

See also: New Indications and Dosage Forms for August 2020

August 2020

Blenrep (belantamab mafodotin-blmf) Injection

Date of Approval: August 5, 2020
Company: GlaxoSmithKline plc
Treatment for: Multiple Myeloma

Blenrep (belantamab mafodotin-blmf) is a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with relapsed or refractory multiple myeloma.

Lampit (nifurtimox) Tablets

Date of Approval: August 6, 2020
Company: Bayer
Treatment for: Chagas Disease

Lampit (nifurtimox) is a nitrofuran antiprotozoal used for the treatment of Chagas disease (American Trypanosomiasis) in pediatric patients.

Evrysdi (risdiplam) for Oral Solution

Date of Approval: August 7, 2020
Company: Genentech
Treatment for: Spinal Muscular Atrophy

Evrysdi (risdiplam) is a survival of motor neuron 2 (SMN2) splicing modifier indicated for the treatment of spinal muscular atrophy (SMA) in patients 2 months of age and older.

Olinvyk (oliceridine) Injection - formerly Olinvo

Date of Approval: August 7, 2020
Company: Trevena, Inc.
Treatment for: Pain

Olinvyk (oliceridine) is an opioid agonist for the management of moderate to severe acute pain in adults.

Viltepso (viltolarsen) Injection

Date of Approval: August 12, 2020
Company: NS Pharma, Inc.
Treatment for: Duchenne Muscular Dystrophy

Viltepso (viltolarsen) is an antisense oliogonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.

Enspryng (satralizumab-mwge) Injection

Date of Approval: August 14, 2020
Company: Genentech
Treatment for: Neuromyelitis Optica Spectrum Disorder

Enspryng (satralizumab-mwge) is an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

Kesimpta (ofatumumab) Injection

Date of Approval: August 20, 2020
Company: Novartis
Treatment for: Multiple Sclerosis

Kesimpta (ofatumumab) is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Cystadrops (cysteamine hydrochloride) Ophthalmic Solution

Date of Approval: August 19, 2020
Company: Recordati Rare Diseases Inc.
Treatment for: Corneal Cystine Crystal Accumulation

Cystadrops (cysteamine hydrochloride) is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.

Winlevi (clascoterone) Cream

Date of Approval: August 26, 2020
Company: Cassiopea SpA
Treatment for: Acne

Winlevi (clascoterone) cream is a first-in-class topical androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Sogroya (somapacitan-beco) Injection

Date of Approval: August 28, 2020
Company: Novo Nordisk
Treatment for: Adult Human Growth Hormone Deficiency

Sogroya (somapacitan-beco) is a human growth hormone analog indicated for the replacement of endogenous growth hormone in adults with growth hormone deficiency.

Xaracoll (bupivacaine hydrochloride) Implant

Date of Approval: August 28, 2020
Company: Innocoll Holdings Limited
Treatment for: Postsurgical Pain Relief Following Open Inguinal Hernia

Xaracoll (bupivacaine hydrochloride) is a fully bioresorbable collagen implant containing the local anesthetic bupivacaine indicated for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair.

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