New Presents from the FDA Leave a comment


(RxWiki News) It’s the holiday season, and the US Food and Drug Administration (FDA) has a gift for all of us. Keep reading to see what the FDA has in its bag of goodies for us this holiday season.

The FDA has recently approved the following new medications:


Xospata was approved to treat acute myeloid leukemia (AML) that is caused by a certain genetic mutation and is getting worse or becoming difficult to treat. AML is a type of blood and bone marrow cancer. This often starts in the bone marrow, where new blood cells are made, and spreads into the blood and parts of the body.

Xospata comes in a film-coated tablet. This medication works by causing cancer cells containing a certain genetic mutation to stop growing and die. Xospata might not be right for you if you have certain heart conditions, pancreas problems, or a known allergy to Xospata or any of its ingredients.


Gamifant has been approved to treat a rare condition called hemophagocytic lymphohistiocytosis (HLH). This condition occurs when the body makes too many activated immune cells like macrophages and lymphocytes. Gamifant belongs to a group of drugs called monoclonal antibodies. These work by binding to interferon gamma and neutralizing it. This results in decreased immune cell production.

Gamifant is only available in an injectable form that has to be given directly into a vein (IV) by a health care professional. Before using this medication, patients may need treatment to prevent certain conditions caused by herpes zoster, pneumocystis jirovecii and some fungi.


Aemcolo has been approved to treat adults with travelers’ diarrhea that is caused by certain strains of E. coli. This medication comes in a delayed-release tablet and is to be swallowed whole. Aemcolo works by blocking a section of a bacterial enzyme called DNA-dependent RNA polymerase. Blocking this enzyme prevents the bacteria from making proteins and growing.

This medication is not recommended in those with diarrhea with a fever or those who have blood in the stool. Also, this medication is not for you if you have an allergy to any rifamycin-class antibiotics or to Aemcolo or any of its ingredients.


Yupelri has been approved to treat chronic obstructive pulmonary disease (COPD). This medication comes in an inhalation solution that has to be inhaled via a jet nebulizer machine. Yupelri works by blocking the actions of a molecule, acetylcholine, at one of its receptors (type 3 muscarinic receptor), causing sections of your airway to widen and making it easier for you to breathe.

Yupelri may not be the treatment for you if you have certain conditions like glaucoma or urinary problems. Also, do not use this medication if you know you are allergic to it or any of its ingredients.

Ask your health care provider any questions you have about these or any other new treatments for your condition.


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