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Fidaxomicin

[A190501] Because fidaxomicin contains an 18-membered lactone ring in its structure, it is referred to as a macrocyclic lactone antibiotic drug. … [A190516] The FDA initially approved fidaxomicin in May 2011 for the treatment of _C. difficile_-associated diarrhea in adult patients over the age of 18.

PW2101

The drug was developed by Penwest Pharmaceuticals and in 2005 the FDA issues a Non-Approval letter due to the degree of kinetic variability of PW2101 observed among individuals.

Propiolactone

[A32144] It is currently FDA approved for its use as an indirect additive used in food contact substances. Propiolactone was first commercially available in the United States in 1958.[A32144]

Dihydrotachysterol

A vitamin D that can be regarded as a reduction product of vitamin D2.

Ensifentrine

[L50903] On June 26, 2024, the FDA announced the approval of an inhaled product of ensifentrine for the treatment of chronic obstructive pulmonary disease (COPD) in adults, which allows the drug to be

Betahistine

[A220333,L16403] Betahistine was first approved by the FDA in the 1970s but withdrawn within approximately 5 years due to a lack of evidence supporting its efficacy.

Eladocagene exuparvovec

[A253687] It was subsequently approved by the FDA in November 2024.[L51898,L51893]

Tradipitant

[A275353] Approved by the FDA on December 30, 2025, tradipitant is indicated for the prevention of vomiting induced by motion.

Sumanirole

Acetarsol

It was developed by Neolab Inc, and approved by Health Canada as an antifungal on December 31, 1964. It has been canceled and withdrawn from the market since August 12, 1997.[L1113]