SAVIENT PHARMACEUTICALS SUBMITS NDA FOR SOLTAMOX TO THE FDA

Savient Pharmaceuticals has submitted a new drug application (NDA) to the FDA for Soltamox (tamoxifen oral liquid solution) for the treatment of hormonally sensitive breast cancer.

Soltamox is the product of Savient's wholly owned subsidiary, Rosemont Pharmaceuticals. located in Leeds, UK. Soltamox represents the first potential product entry into the U.S. from Savient's UK subsidiary, the company said.

Soltamox is currently sold in the UK and will be marketed in Germany under a recently announced collaboration with O.R.C.H.A.PHARM GmbH. Rosemont Pharmaceuticals recently completed a series of modifications to its UK-based liquids manufacturing facility to meet the FDA's current good manufacturing practices.