Glenmark gets USFDA nod for skin infections cream
New Delhi: Glenmark Pharmaceuticals today said it has received approval from the US health regulator for its generic Hydrocortisone Butyrate Cream used for treating variety of skin infections.
Glenmark Generics Inc USA, the subsidiary of Glenmark Generics Ltd has received nod for its Hydrocortisone Butyrate Cream USP (0.1 percent), abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (USFDA), Glenmark Pharmaceuticals said in a statement.
The company is entitled to 180 days of exclusivity with respect to the product as it is the first generic company to file an ANDA for the product, it added.
"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 commercialisation of generic version of Locoid Lipocream and agreed to launch it near the end of CY 2013," Glenmark Pharmaceuticals said.
According to IMS Health sales data for the 12 month period ending June 2013, Hydrocortisone Butyrate Cream garnered annual sales of nearly USD 34 million, it added.
The company's product is a generic version of Triax's Locoid Lipocream.
"Hydrocortisone Butyrate cream is indicated for the relief of the inflammatory and pruritic manifestations of orticosteroid-responsive dermatoses in adults and the treatment of mild to moderate atopic dermatitis in patients 3 months to 18 years of age," Glenmark Pharmaceuticals said.
The company's current portfolio consists of 90 products authorised for distribution in the US market and 53 ANDA's pending approval with the USFDA, it added.
Shares of Glenmark Pharmaceuticals were today trading at Rs 533.05 per scrip in the afternoon trade on BSE, up 1.95 per cent from its previous close.
More from India
More from World
More from Sports
More from Entertaiment
- Dadri lynching: Is Kejriwal spreading poison between Hindus and Muslims?
- Lalu Prasad calls beef eating people uncultured
- Why did Indrani Mukerjea attempt suicide?
- Dadri lynching: Locals stop Arvind Kejriwal from entering Bisara village
- Muslims asked to sprinkle cow urine on body in order to be part of Garba festivities
- Sonia begins Bihar polls campaining; accuses PM Modi of 'narrow-mindedness'
- Salman Khan’s ‘Prem Ratan Dhan Payo’ trailer creates a record!
- Indrani Mukerjea's FSL report rules out drug overdose, says no chemicals found in stomach wash
- Lynching case in Dadri: Rahul meets victim Iqlakh's family, says touched by people's desire to maintain harmony
- Muslims banned from Garba in Gujarat's Mandvi; Hindus asked to sprinkle cow urine on themselves