New Drugs Approved In January

(RTTNews) - In January, the FDA approved two drugs. One is a biosimilar for the treatment of breast cancer and the other is a nasal spray for migraine.

Ontruzant, a biosimilar referencing Herceptin was approved on January 18 for the treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer.

Developed by Samsung Bioepis, Ontruzant is distributed in the United States by Merck.

In 2018, Herceptin brought in sales of CHF 2,908 million in the united states.

The drug comes with boxed warning of Cardiomyopathy, Infusion Reactions, Pulmonary Toxicity and Embryo-Fetal Toxicity.

Ontruzant was approved by the European Commission in November 2017 and Merck launched the drug in the United Kingdom in March 2018.

The nasal spray Tosymra, developed by Dr. Reddy's Laboratories has been approved on January 27 for the acute treatment of migraine with or without aura in adults.

Tosymra nasal spray is formulated using a proprietary novel excipient known as Intravail to achieve blood levels similar to a 4-mg sumatriptan subcutaneous injection, resulting in rapid onset of action.

The company is working toward commercialization of this product.