Zydus Cadila gets approval for two drugs in the US

Zydus Cadila said it received the final regulatory approval to market anti-sleep drug Modafinil in the US, and tentative approval for bladder control drug Solifenacin Succinate.

Unlike a final approval, tentative approvals don’t allow the grantee to sell the drugs in the US market immediately. They have to wait for the patents to expire.

The sales of Modafinil tablets USP are estimated at S148.66 million, indicating that it is a medium sized drug in terms of sales, while that of Solifenacin Succinate is estimated at $1.04 billion.

Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnoea or shift work disorder.

Solifenacin Succinate tablets are indicated for the treatment of overactive 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 abbreviated applications, meant for generics, since the commencement of the filing process in FY 2003-04.