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Cadila Healthcare Ltd (Zydus Cadila) on Friday announced that the company has received final approval from the US drug regulator US Food and Drug Administration (USFDA) to market Modafinil tablets USP.
The tablets, to be sold in 100 mg and 200 mg, are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnoea or shift work disorder, the company informed here.
The group also received the tentative approval for Solifenacin Succinate tablets in strengths of 5 mg and 10 mg, which are indicated for the treatment of over-active bladder associated with symptoms of urinary incontinence and urinary frequency.
Both the drugs will be manufactured at the group’s formulations manufacturing facility at the Pharma SEZ, Ahmedabad.
The group now has more than 150 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.
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