Healthcare Industry News: HSMN NewsFeed

Biopharmaceuticals Generics FDA

 News Release - December 10, 2020

FDA Approves Novadoz Pharmaceuticals Toremifene and Aminocaproic Acid, Bolstering their Continued Growth in Generics

PISCATAWAY, N.J., Dec. 10, 2020 -- (Healthcare Sales & Marketing Network) -- MSN Labs, based in Hyderabad India, recently received FDA approval to market their generic versions of Toremifene 60mg tablets, (AB rated to Kyowa Kirin's Farestonę) & Aminocaproic Acid 500mg tablet, (AB rated Clover's Amicarę) under the Novadoz label. Novadoz is the U.S sales and marketing affiliate for MSN's portfolio of finished dosage forms. The company has commenced shipping of Toremifene, with Aminocaproic Acid to begin shortly.

Toremifene 60mg, an estrogen agonist/antagonist for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor-positive or unknown tumors. The product is supplied in bottles of 60 tablets. It represents an addition to the company's growing line of specialty oncology products, which include Abiraterone 250mg tablets, Capecitabine 150mg and 500mg tablets, Fosaprepitant 150mg vial for injection, Decitabine 50mg vial for injection, and Thiotepa 15mg and 100mg vials for injection.

Aminocaproic Acid 500mg tablets are indicated in the use of enhancing hemostasis when fibrinolysis contributes to bleeding. It is primarily utilized when rapid dissolving of blot clots occurs. The product is supplied in bottles of 30 tablets.

Seshu Akula, Novadoz President North America Generics, states, "In a year when our organization and industry have faced major constraints, we are very pleased to introduce Toremifene 60mg tablets which adds to our growing basket of oncology products. Aminocaproic Acid 500mg is another niche portfolio addition, providing significant value to our customers and consumers alike. The company expects to continue its strategy of introducing specialty and high volume products to the market over the next twelve to thirty-six months."

He adds, "MSN continues to deliver on its commitment to R&D and manufacturing, supplying our existing products near a 100% service level. The organization accomplishes this while maintaining a micro focus on quality demonstrated with an excellent history of FDA facility audits"

MSN Labs is engaged in the development and manufacturing of API (active pharmaceutical ingredients), KSMs (key starting materials), and product intermediates. MSN is a global leader in this category. Additionally, the company also manufactures oral solids, liquids, and specialty injectable products in sixty-five markets throughout the world, doing business in the U.S. as Novadoz Pharmaceuticals.

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


Source: Novadoz Pharmaceuticals

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