Product news

Share this article:

Critical Therapeutics said the FDA has approved the company’s New Drug Application (NDA) for twice-daily Zyflo CR(zileuton) extended-release tablets. Critical Therapeutics, together with its co-promotion partner Dey expect to begin marketing Zyflo CR in the US in the fall of 2007. Zyflo CR and Zyflo (zileuton tablets) are the only FDA-approved leukotriene synthesis inhibitors for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.

 

Upsher-Smith Laboratories received approval from the FDA for the marketing of Divigel (estradiol gel) 0.1 percent -- the lowest approved dose of estradiol available for the treatment of moderate to severe hot flashes associated with menopause.

Share this article:
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

India's Marck gets FDA Warning Letter

Inspectors of Marck Biosciences found an array of problems during a October-November 2013 inspection, including mold near a sterile area that was so bad "the room had 'partially caved in.'"

DOJ closes Brilinta investigation

AstraZeneca announced the end of the investigation Tuesday.

Doctors back unique biosimilar names

A host of doctors has asked FDA Commissioner Margaret Hamburg to back a naming convention that would require biologics and biosimilars to have different names.