New Delhi: Drug firm Zydus Cadila on Friday said it has received approval from the US health regulator for its Modafinil and Solifenacin Succinate tablets, and the drugs will be manufactured at Ahmedabad facility.
The company 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.
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 group 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.
The group now has more than 150 approvals and has so far filed over 300 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process by the company, it added.