Date: 2011-12-19
Type of information: Granting of a Market Authorisation in the USA
Product name: Allegra® OTC
Compound: fexofenidine
Therapeutic area: Allergic diseases
Action mechanism: antihistaminic
Company: Sanofi-Aventis (France) Chattem (USA)
Disease: relief of symptoms associated with seasonal allergies in patients 12 years of age and older.
Latest news: FDA has approved the Allegra® (fexofenadine HCl) family of allergy medication products for over-the-counter (OTC) use in adults and children two years of age and older. The Allegra® family of products will be available in the United States without a prescription in March 2011.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: 2011-01-25 Other news: