FDA approves Taro’s acne generic
ROCKVILLE, Md. The Food and Drug Administration has approved a generic version of an acne drug.
The agency approved Taro Pharmaceutical Industries’ sulfacetamide sodium lotion in the 10% strength.
The lotion is a generic version of Sanofi-Aventis’ Klaron. Klaron and its generic equivalents had sales of approximately $15 million for the 12 months ended March 31, according to Taro.
J&J: Agreements with Schering-Plough void after Merck merger
NEW BRUNSWICK, N.J. The planned merger between Schering-Plough Corp. and Merck & Co. would permit the termination of agreements between Schering-Plough and Johnson & Johnson’s biotech division, J&J asserted in an arbitration demand filed Wednesday with the American Arbitration Association, an alternative dispute resolution organization.
The drug maker said the planned merger constituted a change of control that would allow the termination between agreements its Centocor Ortho Biotech division made with Schering-Plough regarding the inflammatory and immunological disease drugs Remicade (infliximab) and Simponi (golimumab).
“As its public statements have made clear, Merck is acquiring Schering-Plough,” J&J said in a statement. “The acquisition constitutes a change of control that tribbers the right of our Centocor Ortho Biotech subsidiary to terminate the agreements.”
FDA accepts approval application from Warner Chilcott
ARDEE, Ireland The Food and Drug Administration has accepted an approval application for a low-dose oral contraceptive from Warner Chilcott, the drug maker announced Wednesday.
The agency accepted Warner Chilcott’s new drug application for WC 3016, submitted through a subsidiary on March 26.
The company recently relocated its headquarters from Bermuda to Ireland.