Novitium Pharma LLC announced that it has received U.S. Food and Drug Administration approval of its Abbreviated New Drug Application (“ANDA”) for Thiothixene Capsules USP, and has immediately initiated limited distribution activities.
Thiothixene Capsules USP 1mg, 2mg, 5mg, and 10mg are all listed on the FDA’s drug shortages list. Thiothixene Capsules USP is a therapeutic equivalent to the reference listed drug Navane® Capsules of Pfizer Inc.
Novitium is a U.S. based pharmaceutical company that specializes in development, manufacturing, and distribution of niche generic pharmaceutical products. The company, founded in 2016, has since established a growing commercial product portfolio and developed a pipeline of over 20 ANDAs filed with the FDA, spanning a diverse range of dosage forms and therapeutic categories. Novitium continues to invest in producing affordable, high-quality medications to fulfill the needs of pharmacists, patients, and communities alike.