logo
Share SHARE
FONT-SIZE Plus   Neg

Glenmark Generics Receives Approval For Hydrocortisone Butyrate Cream USP, 0.1%

Glenmark Pharmaceuticals Ltd. said its US subsidiary Glenmark Generics Inc. had received the approval from US FDA for Hydrocortisone Butyrate Cream USP, 0.1 percent, abbreviated new drug approval (ANDA), a generic version of Locoid Lipocream.

In April 2011, Glenmark had entered into a royalty-bearing license agreement with Triax Pharmaceuticals, Astellas Pharma Europe BV and Astellas Pharma International BV to settle a patent infringement suit against the commercialization of generic version of Locoid Lipocream and agreed to launch in near the end of CY2013. Glenmark is entitled to 180 days of exclusivity with respect to its Hydrocortisone Butyrate Cream, as it is the first generic company to file an ANDA for the product.

Hydrocortisone Butyrate Cream is indicted for the Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults and the treatment of mild to moderate atopic dermatitis in patients 3 months to 18 years of age.

According to ISM Health sales data, Hydrocortisone Butyrate Cream had sales of around $34 million for the 12 months ended June 30, 2013.

AT the BSE, Glenmark Pharmaceuticals shares are currently trading at Rs.530.95, up 1.55 percent from the previous close.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

More Breaking News

0 Articles
Editors Pick
The Germanwings plane crash has spurred European airlines to implement stringent cockpit rules widely followed in the U.S., after it emerged a lone co-pilot forced the plane into its fatal descent, reports said on Thursday. Video-game retailer GameStop Corp. said Thursday after the markets closed that its fourth quarter profit rose 11% from last year, as better cost control helped offset a 5.6% decrease in sales. However, the company's quarterly earnings per share, excluding item, came in below analysts' expectations as did its quarterly sales. The Villages, a serene retirement hometown in Florida has been designated as the fastest-growing metro in the U.S. for the second consecutive year, as per Census estimates released on Thursday.
comments powered by Disqus
Follow RTT