Dr Reddys gets USFDA approval for fexofenadine hydrochloride
Mumbai, April 13 (UNI) Dr Reddys Laboratories Ltd., has received US Food and Drug Administrations final approval for the companys abbreviated new drug application (ANDA) for fexofenadine hydrochloride tablets.
Informing the BSE, the company said it will commence the commercial marketing of this product immediately. In September 2002, the company filed the ANDA for fexofenadine hydrochloride tablets 30 mg, 60 mg and 180 mg with a para IV certification on all orange book patents.
Fexofenadine hydrochloride is the AB-rated generic equivalent of Sanofi-Aventis Allegra. Allegra is indicated for the relief of symptoms associated with seasonal allergic rhinitis and for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
As per IMS December 2005, the product had annual US brand sales of approximately USD 1.4 billion.
UNI SN PP VKG1625