The Drug company Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Modafinil tablets USP in the strengths of 100 mg and 200 mg, Zydus Cadila said in a statement. It also stated that the drugs will be manufactured in Ahemdabad.
The product is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnoea or shift work disorder, it added.
The firm has also received the tentative approval for Solifenacin Succinate tablets in strengths of 5 mg and 10 mg, Zydus Cadila said.
The tablets are indicated for the treatment of overactive bladder associated with symptoms of urinary incontinence and urinary frequency, it added.
“Both the drugs will be manufactured at the group’s formulations manufacturing facility at the Pharma SEZ, Ahmedabad,” Zydus Cadila said.
Shares of Cadila Healthcare, the listed entity of the group today closed at Rs 479.05 per scrip on BSE, down 0.36 per cent from its previous close.