J&J Gets FDA Approval for Sirturo, Lexicon Wins Fast Track for LX1033: Healthcare Business Update
Johnson & Johnson (NYSE:JNJ) on Monday won an accelerated FDA approval for its tuberculosis tablet Sirturo, representing the first medicine in 40 years that provides a new manner in which to treat the disease. The agency cleared the drug to be added to existing therapies for use by adults whose case is resistant to multiple drugs, according to a company statement.
Lexicon Pharmaceuticals (NASDAQ:LXRX) said Monday that it has received “Fast Track” status from the FDA for the development of LX1033, which is an orally-delivered small molecule drug candidate for diarrhea-predominant irritable bowel syndrome. Lexicon is a biopharmaceutical company that concentrates upon finding and developing breakthrough treatments for human disease.
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On Monday, Salix Pharmaceuticals (NASDAQ:SLXP) won FDA approval for its Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients who are taking antiretroviral therapy, which is a combination of drugs used to treat HIV infection. Fulyzaq is intended to be used in such patients whose diarrhea is not caused by an infection from a virus, bacteria, or parasite. Patients use Fulyzaq twice daily to control watery diarrhea from the secretion of electrolytes and water in the gastrointestinal tract. The medication is derived from the red sap of the Croton lechleri plant, and marks the second botanical prescription drug approved by the FDA.
Endologix (NASDAQ:ELGX) said that its distribution partner in Japan, Cosmotec, gets Shonin approval from the Ministry of Health, Labor and Welfare of Japan, to market the IntuiTrak Delivery System, which delivers the firm’s Powerlink anatomical fixation stent graft for a minimally invasive endovascular repair of abdominal aortic aneurysms . The company is a developer and marketer of innovative treatments for aortic disorders.