FDA approves pink eye treatment
ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for treating a common eye infection.
The agency announced Thursday the approval of Bausch & Lomb’s Besivance (besifloxacin ophthalmic suspension, 0.6%) for treating bacterial conjunctivitis, commonly known as pink eye. The infection, which can occur in people in any age but is most common in children, causes eye irritation, swelling and discharge from the eyes. The drug is not approved for treating viral conjunctivitis.
“Bacterial conjunctivitis is a common condition that affects people of all ages,” FDA Center for Drug Evaluation and Research Division of Anti-Infective and Ophthalmology Products acting director Wiley Chambers said. “It is important to have a variety of treatment options available to healthcare professionals and patients because an effective drug therapy can reduce the duration of the illness and reduce the chances of infecting others.”
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.