Generics

Meitheal has exclusive U.S. rights to Yusimry and responsibility for all commercial activities nationally.

Prochlorperazine edisylate injection is indicated to treat nausea and vomiting as well as the treatment of schizophrenia.

The Biosimilars Council is calling for inclusion of an affirmative statement to allow for a better understanding of treatment options and more affordable medicines.

Sodium Bicarbonate Injection is indicated in the treatment of metabolic acidosis from severe renal disease, uncontrolled diabetes and cardiac arrest.

Liraglutide injection is indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with Type 2 diabetes.

Xifaxan 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea in adults.

Tranexamic acid injection is indicated in patients with hemophilia for short-term use to reduce or prevent hemorrhage during tooth extraction.

The draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product.