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New Drug Approvals Archive - January 2020

See also: New Indications and Dosage Forms for January 2020

January 2020

Ayvakit (avapritinib) Tablets

Date of Approval: January 9, 2020
Company: Blueprint Medicines Corporation
Treatment for: Gastrointestinal Stromal Tumor

Ayvakit (avapritinib) is a kinase inhibitor for the treatment of PDGFRα exon 18 mutant gastrointestinal stromal tumors (GIST).

Valtoco (diazepam) Nasal Spray

Date of Approval: January 10, 2020
Company: Neurelis, Inc.
Treatment for: Epilepsy

Valtoco (diazepam) is a benzodiazepine nasal spray for the short-term treatment of epilepsy cluster seizures.

Numbrino (cocaine hydrochloride) Nasal Solution

Date of Approval: January 10, 2020
Company: Lannett Company, Inc.
Treatment for: Nasal Anesthesia

Numbrino (cocaine hydrochloride) nasal solution is a local anesthetic indicated for the introduction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults.

Tepezza (teprotumumab-trbw) Injection

Date of Approval: January 21, 2020
Company: Horizon Therapeutics plc
Treatment for: Thyroid Eye Disease

Tepezza (teprotumumab-trbw) is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor 1 receptor (IGF-1R) for the treatment of active thyroid eye disease (TED).

Tazverik (tazemetostat) Tablets

Date of Approval: January 23, 2020
Company: Epizyme, Inc.
Treatment for: Epithelioid Sarcoma

Tazverik (tazemetostat) is a methyltransferase inhibitor for the treatment of patients with epithelioid sarcoma.

Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Extended-Release Tablets

Date of Approval: January 27, 2020
Company: Boehringer Ingelheim and Eli Lilly and Company
Treatment for: Diabetes Type 2

Trijardy XR (empagliflozin/linagliptin/metformin hydrochloride) is a fixed-dose combination of the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance), the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin (Tradjenta) and the biguanide metformin hydrochloride indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Monoferric (ferric derisomaltose) Injection

Date of Approval: January 16, 2020
Company: Pharmacosmos Therapeutics Inc.
Treatment for: Iron Deficiency Anemia

Monoferric (ferric derisomaltose) is an intravenous iron replacement product indicated for the treatment of iron deficiency anemia.

Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp) - formerly AR101

Date of Approval: January 31, 2020
Company: Aimmune Therapeutics, Inc.
Treatment for: Peanut Allergy

Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp) is an oral immunotherapy indicated to help reduce the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut.

Audenz (influenza A (H5N1) monovalent vaccine, adjuvanted) Injection

Date of Approval: January 31, 2020
Company: Seqirus
Treatment for: Influenza Prophylaxis

Audenz (influenza A (H5N1) monovalent vaccine, adjuvanted) is a cell-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic.

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