Glenmark gets final nod from USFDA for skin infection cream

Glenmark Pharmaceuticals has received final approval from the US health regulator for its generic

RELATED ARTICLES

Fluocinonide cream used for treating a variety of skin infections.

Glenmark Generics Inc USA, the subsidiary of Glenmark Generics Ltd, has been granted final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Fluocinonide cream USP (0.1%), Glenmark Pharmaceuticals said in a statement.

"According to IMS Health sales data for the twelve-month period ending March 2014, Fluocinonide cream garnered annual sales of approximately $103 million," it added.

The company's product is the generic version of Medicis's Vanos cream.

"Fluocinonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses," Glenmark said.

The company's current portfolio consists of 93 products authorised for distribution in the US market and it has 71 ANDA's pending approval with the USFDA, it added.

Shares of Glenmark Pharmaceuticals were today trading at Rs 546.35 per scrip in the morning trade on BSE, up 1.34% from its previous close.

Post new comment

E-mail ID will not be published
CAPTCHA
This question is for testing whether you are a human visitor and to prevent automated spam submissions.

EDITORIAL OF THE DAY

  • It will take at least 4 more quarters for corporate bottomlines to turn around

    Aggregate numbers from corporate results in the June quarter of 2014-15 are hardly different from the previous six quarters, with no positive surprise

FC NEWSLETTER

Stay informed on our latest news!

INTERVIEWS

GV Nageswara Rao

MD & CEO, IDBI Federal Life

Timothy Moe

Goldman Sachs

Chander Mohan Sethi

CMD, Reckitt Benckiser India

COLUMNIST

Tushar Gandhi

Dealing with a sin called insensitivity

Rage and the notion of being above the law — ...

Kuruvilla Pandikattu SJ

India’s greatest gift to the world

What we hear most often about India these days is ...

Gautam Gupta

Why must innerwear be our best kept secret?

While women’s outerwear rules the marketing roost in India, unfortunately, ...

INTERVIEWS

William D. Green

Chairman & CEO, Accenture