MSN Labs obtains FDA OK for two generics

The Food and Drug Administration has given the green light to MSN Labs for toremifen, the generic of Kyowa Kirin's Fareston.

The FDA also approved the company's aminocaproic acid, which is the generic of Clover's Amicar.  

Novadoz has commenced shipping of toremifene, with aminocaproic acid to begin shortly.

Toremifene is an estrogen agonist/antagonist for the treatment of metastatic breast cancer in postmenopausal women with estrogen receptor-positive or unknown tumors. The product is available in a dosage strength of 60 mg and comes in bottles of 60 tablets. 

Aminocaproic acid, which is available in a dosage strength of 500 mg, is 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 available in bottles of 30 tablets.

"In a year when our organization and industry have faced major constraints, we are very pleased to introduce Toremifene 60 mg tablets which adds to our growing basket of oncology products. Aminocaproic acid 500 mg 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 12 to 36 months," said Seshu Akula, Novadoz president North America generics.