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

Penn and Teller give take on vaccines

The Las Vegas twosome give the anti-vaccination movement their signature treatment.

GSK allegations build in Jordan and Lebanon

GlaxoSmithKline says it is investigating allegations of employee misconduct. The company said in a statement that the allegations have numbers "very similar to those reported by other companies in our sector."

Generic Celebrex is coming

Pfizer and Teva's settlement puts generic Celebrex on the market by December.