Thursday, September 19, 2019

Thursday, September 19, 2019

NOVADOZ PHARMACEUTICALS: MSN Labs/Novadoz Pharmaceuticals Early Success Continues With FDA Approval Of Generic Abiraterone


Novadoz Pharmaceuticals issued the following announcement on July 15.

MSN Labs, the parent company of Novadoz Pharmaceuticals, was granted FDA approval to market Abiraterone Acetate 250mg tablets, a generic version of Janssen Pharmaceuticals' product Zytiga©, on July 9th.  This FDA approval marks the ninth since March 2018, when Novadoz began commercial operations as MSN Labs' U.S sales and marketing affiliate for their finished dosage forms.  The company expects additional product launches over the next 12 months continuing the organization's meteoric entrance, and rise in the U.S market.

MSN's approval for Abiraterone Acetate 250mg tablets, in the class of oncology drugs indicated for the treatment of prostate cancer when used with a steroid medication (prednisone or methylprednisolone).  The product is available in 120 tablet count bottles.   This is the second oncology product launched by Novadoz, the first Capecitabine 150mg & 500mg tablets, their generic version of Novartis' Xeloda©,  indicated for the treatment of breast cancer.   Abiraterone Acetate 250mg tablets are currently trending over $997MIL in brand and generics sales, as well as an approximate 9%  increase in prescriptions since 2016 according to published reports. 

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

"The approval of generic Abiraterone is a significant for our organization as it continues to fill our portfolio with important products, most specifically those used in the oncology class.  These products offer great value to patients and our customers, and continue to build on Novadoz's successful entrance in the U.S market.   We are continuing to focus on our plans to launch 10 to 12 additional products in the next 12 to 18 months."

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

"Since we have experienced early success supplying generics in a reliable and consistent basis with our customers, we are confident in our efforts to achieve additional success with Abiraterone 250mg tablets.  Our vertical integration with API, and backward integration with key starting materials and intermediates, along with a robust pipeline of generics plays a strong factor in our company's continued success."

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.

Original source can be found here.

Organizations in this Story

Novadoz Pharmaceuticals

More News

FDA Reporter