Zydus Cadila has received the final approval from the United States Food & Drug Administration (USFDA) to market Modafinil tablets USP, 100 mg and 200 mg. Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnoea or shift work disorder. The sales of Modafinil tablets USP are estimated at $148.66 million, as per IMS Health.
The group also received the tentative approval for Solifenacin Succinate tablets in strengths of 5 mg and 10 mg. Solifenacin Succinate tablets are indicated for the treatment of overactive bladder associated with symptoms of urinary incontinence and urinary frequency. The sales of Solifenacin Succinate tablets are estimated at $1.04 billion, as per IMS Health.
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.
