Zydus Lifesciences Secures USFDA Nod for Deflazacort Suspension
Zydus Lifesciences Ltd has secured USFDA approval for its generic version of Deflazacort oral suspension. The medication, used to treat Duchenne Muscular Dystrophy, will be produced in Doppel, Italy. Designed for patients aged five and up, Deflazacort helps manage inflammation and an overactive immune response.
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Zydus Lifesciences Ltd has announced that it received final approval from the U.S. Food and Drug Administration for its generic version of Deflazacort oral suspension. This medication is used to treat a severe form of inherited muscular dystrophy known as Duchenne Muscular Dystrophy (DMD).
The approval confirms that their Deflazacort oral suspension, with a strength of 22.75 mg/ml, meets USFDA standards. Zydus Lifesciences Ltd disclosed this development in a recent regulatory filing, further cementing its presence in the pharmaceutical sector.
The treatment is intended for patients aged five and older, functioning as a steroid that reduces inflammation and regulates an overactive immune system. Production is set to take place in Doppel, Italy, marking an important milestone for the company in expanding its international reach.
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