Zydus Cadila receives USFDA approval for arsenic trioxide injection

The US drug regulator has granted final approval for arsenic trioxide injection used to treat certain type of leukemia.

Zydus Cadila informed the bourses on Wednesday post lunch that the company has received the final approval from the United Stated Food and Drug Administration (USFDA) to market arsenic trioxide as 10 mg/10 mL (1 mg/mL) single-dose injection (TRISENOX). The injection will be manufactured at Alidac Pharmaceuticals Limited, the company's subsidiary located Ahmedabad, Gujarat.

The medication arsenic trioxide is used to treat acute promyelocytic leukemia-APL, in cases when other treatments such as chemotherapy have failed to work.

Earlier, during the week, Zydus receives USFDA's final approval for Nystatin and Triamcinolone Acetonide Ointment USP. The ointment is a anti-fungal drug that also contains triamcinolone, an anti-inflammatory corticosteroid that helps reduce swelling, itching and redness.

Zydus Cadila has 228 approvals and has filed for over 330 ANDAs, as of date, since the commencement of the filing process in FY 2003-04.

On Wednesday, the stock of Cadila Healthcare reacted positively to this development and closed at Rs. 370.25 per share, up by Rs. 14.70 or 4.13 per cent on BSE.