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
Can a washing machine explode just like a bomb? A lawsuit filed in the federal court in New Jersey alleged that there was loud noise and damage to garage wall as the washing machine went off with a violent boom. Samsung is facing federal class action lawsuit from customers. There were similar reports... German lender Commerzbank AG said Thursday that it will cut almost 10,000 jobs, stop paying dividends for the time being and merge two big units as part of a restructuring to become profitable on a sustainable basis by 2020. The bank, Germany's second largest, said that to cover its restructuring costs in the region of 1.1 billion euros, it will cease dividend payments for the time being. Apple Inc. has repeatedly assured customers of its commitment to privacy and said that iMessage conversations are safe. However, Apple's iMessage logs the phone numbers typed by users for a text conversation and shares this information with law enforcement when compelled by court order, according to news site "The Intercept."
comments powered by Disqus
Follow RTT