logo
Plus   Neg
Share
Email

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 RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

More Breaking News

0 Articles
Editors Pick
Shares of Deutsche Bank were losing around 2 percent in German trading after the banking giant reported lower profit and revenues in its first quarter with weakness in all segments, mainly Corporate & Investment Bank. Separately, the bank announced actions to reshape its Corporate & Investment Bank and additional cost-cutting measures, including job cuts. Hershey Co. (HSY) on Thursday reaffirmed its adjusted earnings guidance for the full-year 2018 in the range of $5.33 to $5.43 range, an increase of 14 to 16 percent from 2017. However, reported earnings are now expected to be in the range of $4.73 to $4.98 per share, an increase of $0.02 per share... Automaker General Motors Co. on Thursday reported a 60 percent fall in profit for the first quarter from last year, reflecting lower revenues and a charge related to the company's Korean operations restructuring. However, adjusted earnings per share for the quarter beat analysts' estimates and the company affirmed its financial outlook for fiscal 2018.
Follow RTT