New Drug Approvals Archive - January 2020

Ayvakit (avapritinib) Tablets

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

Ayvakit (avapritinib) is a kinase inhibitor for the treatment of PDGFRα exon 18 mutant gastrointestinal stromal tumors (GIST), and advanced systemic mastocytosis (AdvSM).

• FDA Approves Ayvakit (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA Exon 18 Mutant Gastrointestinal Stromal Tumor
• Ayvakit (avapritinib) FDA Approval History

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.

• FDA Approves Valtoco (diazepam nasal spray) as a Seizure Rescue Treatment
• Valtoco (diazepam) FDA Approval History

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.

• FDA Approves Numbrino (cocaine hydrochloride) Nasal Solution for Nasal Anesthesia
• Numbrino (cocaine hydrochloride) FDA Approval History

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).

• FDA Approves Tepezza (teprotumumab-trbw) for the Treatment of Thyroid Eye Disease (TED)
• Tepezza (teprotumumab-trbw) FDA Approval History

Tazverik (tazemetostat) Tablets

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

Tazverik (tazemetostat) is a methyltransferase inhibitor for the treatment of:

• adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
• Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies.
• Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

• FDA Approves Tazverik (tazemetostat) for the Treatment of Patients with Epithelioid Sarcoma
• Tazverik (tazemetostat) FDA Approval History

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.

• FDA Approves Trijardy XR (empagliflozin/linagliptin/metformin) for Type 2 Diabetes in Adults
• Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) FDA Approval History

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.

• FDA Approves Monoferric (ferric derisomaltose) Injection for the Treatment of Iron Deficiency Anemia
• Monoferric (ferric derisomaltose) FDA Approval History

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.

• FDA Approves Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] as First Treatment for Peanut Allergy
• Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp) FDA Approval History

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.

• FDA Approves Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) as First-Ever Adjuvanted, Cell-Based Pandemic Influenza A (H5N1) Vaccine
• Audenz (influenza A (H5N1) monovalent vaccine, adjuvanted) FDA Approval History