PHARMACY

FDA gives tentative approval for Singulair generic

BY Alaric DeArment

PITTSBURGH Mylan has received tentative approval from the Food and Drug Administration for its generic version of a drug used to treat allergies and asthma.

Mylan announced Friday that the FDA had given the tentative approval to its montekulast sodium tablets in the 10-mg strength. The tablets are a generic version of Merck & Co.’s Singulair.

Singulair had U.S. sales of $2.6 billion for the 12 months ended March 31, according to IMS Health data.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
PHARMACY

J&J: Agreements with Schering-Plough void after Merck merger

BY Alaric DeArment

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.”

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
PHARMACY

FDA accepts approval application from Warner Chilcott

BY Alaric DeArment

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.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?