You are here

FDA Approves Ertaczo Cream

Pittsburgh, PA – December 11, 2003 – Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. Food and Drug Administration has approved ERTACZO™ (sertaconazole nitrate) Cream, 2%. Sertaconazole is an imidazole derivative antifungal indicated for the treatment of Tinea Pedis.

In October 2003, Mylan announced the sale of the U.S. and Canadian rights for sertaconazole to the OrthoNeutrogena Division of Ortho-McNeil Pharmaceutical Inc. (OrthoNeutrogena), terminating the licensing rights it held to sertaconazole from Ferrer Internacional S.A. Mylan received $2 million upon signing the agreement with OrthoNeutrogena and will receive the additional $12 million as a result of the FDA’s final approval of its NDA.

The product will be marketed by OrthoNeutrogena.

Source: Mylan Laboratories Inc.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs