Cadila Healthcare hits new high on USFDA approval for new drug

The stock rallied 10% to Rs 539, also its new high on BSE in intra-day trade

Cadila Healthcare rallied 10% to Rs 539, also its new high on BSE in intra-day trade, after Zydus Cadila said the US Food and Drug Administration (USFDA) has given the final approval to market the company’s Mesalamine Delayed-Release tablets USP, 1.2 g in the US market.

Zydus Cadila was the first to file an Abbreviated New Drug Application (ANDA) for a generic version of Lialda (Mesalamine).

“Lialda is indicated for the treatment of mild to moderate ulcerative colitis. Ulcerative colitis is a chronic inflammatory bowel disease that affects approximately 700,000 people in the United States,” the company said in a press release.

The generic version of Lialda (Mesalamine), will be produced at the company’s Moraiya plant located at Ahmedabad.

As per IMS MAT April 2017, the estimated brand sales for Mesalamine delayed-release tablets USP, 1.2 g is US$ 1.145 billion.

In past nine trading sessions, the stock of Cadila Healthcare has outperformed the market by surging 26% as compared to 1.8% rise in the S&P BSE Sensex.

At 10:06 am; it was up 9% to Rs 534 against 0.33% rise in the benchmark index. The trading volumes on the counter jumped nearly four-fold with a  combined 5.57 million shares changed hands on the BSE and NSE so far.