NOVADOZ PHARMACEUTICALS: MSN Labs/Novadoz Pharmaceuticals receives consecutive FDA approvals for their generic versions of Solifenacin and Trientine


Novadoz Pharmaceuticals issued the following announcement on May 28.

It was a very significant week for Novadoz Pharmaceuticals, the U.S sales & marketing affiliate of  The MSN Group (MSN) based in Hyderabad, India.  The company was granted FDA approval to market Solifenacin Succinate tablets, their generic version of Astellas Pharma's product VesiCare©, on May 20th.  MSN also received FDA clearance to market Trientine Hydrochloride 250mg capsules, that  is the company's AB rated generic to Valeant Pharmaceuticals brand Syprine© on May 22nd. 

Solifenacin is available in 5mg and 10mg tablets in 30 and 90 count bottles.  MSN received FDA approval for the Solifenacin Succinate as part of a DAY 1 launch that marked the brand's patent expiration.  The product is in a class of drugs used to treat symptoms of an overactive bladder, such as frequent or sudden urination, and incontinence.  U.S sales of Solifenacin have exceeded $940mil over the previous 12 months.

Trientine 250mg capsules are available in 100 count bottles.  The product is prescribed to treat Wilson's Disease for patients who cannot tolerate penicillamine.  It is a condition where the body stores excess copper.  The total market for Trientine over the previous 12 months exceeded $124mil.

Commenting on the launch, Seshu Akula, President, N.A. Generics – Novadoz Pharmaceuticals, states:

"Our approval of Solifenacin and Trientine keeps with the organization's focus to participate in important DAY 1 launches, as well as introducing niche specialty products that provide tremendous value to the entire pharmaceutical supply chain.  These approvals provide patients significant cost savings as alternatives to higher cost brands."   

Tom DeStefano, Novadoz's Vice President of Sales and Marketing, is quoted:

"We are delighted to launch Solifenacin and Trientine and continue to establish Novadoz's reputation as a reliable and consistent supplier of high quality products to our customers. The value of our finished dosage forms is leveraged with our strength in APIs and backward integration with key starting materials and intermediates. Additionally, we will file upward of 30 ANDAs per year providing our company with a deep and extensive product pipeline."

MSN Labs is engaged in the development and manufacturing of API (active pharmaceutical ingredients), KSMs (key starting materials), and product intermediates.  MSN is currently ranked second in the world in that sector.  In addition, the company manufactures finished dosage oral solids, liquids, & injectable products in sixty-five markets throughout the world.

For more information, visit the company's websites at www.NovadozPharma.com & www.MSNLabs.com.

Original source can be found here.

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