FDA revokes tentative approval of Ranbaxy's generic Nexium and Valcyte

Indian generics drugmaker Ranbaxy Laboratories (BSE: 500359) revealed in a Bombay Stock Exchange filing that it has received communication from the US Food and Drug Administration, in which the agency said it has determined that Ranbaxy’s Abbreviated New Drug Applications of concern did not have any data integrity issues.

However, in what must come as music to the ears of AstraZeneca (LSE: AZN), the FDA has rescinded the previously granted tentative approvals for Ranbaxy’s ANDA for esomeprazole magnesium delayed-release capsules, 20mg and 40mg , a copy version of the Anglo-Swedish pharma major blockbuster gastro-intestinal drug Nexium. Just yesterday, AstraZeneca boosted its full year 2014 profit outlook based on the assumption of no generic competition for Nexium in 2014 (The Pharma Letter November 6). Nexium third-quarter sales were $922 million.

Additionally, Ranbaxy said that the   rescinded the tentative approval for valganciclovir hydrochloride tablets USP, 450mg, a generic version of Swiss pharma major Roche’s (ROG: SIX) anti-viral drug Valcyte.