Dr Reddy's launches generic Aricept, Effexor and Femara in USA; FDA clears Mylan ANDA

Indian generics drug major Dr Reddy’s Laboratories (NYSE: RDY) yesterday announced that it has launched three copy products in the US market, two of which address central nervous system disorders and the third breast cancer. The drugs are:

• Donepezil hydrochloride tablets (5mg and 10mg strengths), a bioequivalent generic version of Japanese drug major Eisia’s blockbuster Alzheimer’s disease drug Aricept. The Food and Drug Administration approved Dr Reddy’s Abbreviated New Drug Application for donepezil on May 31, 2011. The Aricept brand and generic donepezil generated US sales of around $2.3 billion in the 12 months to March 31, according to IMS Health data.
Also, US generics firm Mylan yesterday said it has received FDA approval for its generic version on Aricept, which it plans to launch immediately.

• Venlafaxine hydrochloride extended-release capsules (37.5mg, 75mg and 150mg strengths), a bioequivalent generic version of global drugs behemoth Pfizer’s antidepressant Effexor. The FDA approved Dr Reddy’s ANDA for venlafaxine on May 5. The brand named product plus generics has US sales of $2.3 billion in the year to March.