Novadoz Receives Marketing Approval for Generic Versions of Rosuvastatin, Capecitabine, & Moxifloxacin
Published: Aug 08, 2018
PISCATAWAY, N.J., Aug. 8, 2018 /PRNewswire/ -- Novadoz Pharmaceuticals, the U.S sales & marketing affiliate of MSN Group (MSN) from Hyderabad, India has received approval to market the company's first products, Rosuvastatin, Capecitabine, and Moxifloxacin tablets.
MSN received FDA approval for the cholesterol reducing drug Rosuvastatin Calcium on November 22, 2017. The usage of statin classes of cholesterol reducing agents has increased steadily over the last five years. Moxifloxacin Hydrochloride 400mg, an anti-infective was granted approval by the FDA on September 22, 2017.
MSN's most recent FDA approval came on July 2, 2018 for Capecitabine 150mg & 500mg tablets. Capecitabine is an oncolytic class of drug, indicated for the treatment of breast cancer. Capecitabine unit sales are trending at 30.1 mil tablets per year, and are increasing at a rate of 5.5% annually.
Commenting on the U.S product launches, Dr MSN Reddy, Chairman - MSN Group commented:
"This is a major milestone for MSN Group as we are moving up the value chain. Based on our vertical integration model we are hopeful to bring more affordable medicines to the US Market in the near future."
Seshu Akula, President, North America Generics, for Novadoz quotes:
"The recent approvals for Rosuvastatin, Capecitabine, and Moxifloxacin mark a significant event for the commercialization of the MSN Group's entry into the U.S market with finished dosage forms. Novadoz will benefit from the company's vertical integration of API & intermediates, expertise in product development & technology, along with the company's ability to manufacture high barrier of entry products."
"The company expects 12 more ANDA approvals in the next twelve months. Additionally, we will file 20 to 25 ANDAs per year providing Novadoz with a deep and extensive product pipeline."
MSN Labs is engaged in the development and manufacturing of API (active pharmaceutical ingredients), and is currently ranked second in the U.S for that sector. In addition, the company manufactures finished dosage oral solids, liquids, & injectable products in sixty-five markets throughout the world.
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SOURCE Novadoz Pharmaceuticals