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Products

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:

Is general: Yes