Pharmabiz
 

Lupin get US FDA marketing nod for generic Trizivir tablets

Our Bureau, MumbaiTuesday, December 10, 2013, 15:40 Hrs  [IST]

Pharma major Lupin Ltd., has received final approval for its abacavir sulfate, lamivudine and zidovudine tablets, 300 mg (base)/150 mg/300 mg from the US Food and Drug Administration (FDA) to market a generic version of ViiV Healthcare's Trizivir tablets, 300 mg (base)/150 mg/300 mg.

Lupin's abacavir sulfate, lamivudine, and zidovudine tablets, 300 mg (base)/ 150 mg/ 300 mg is indicated in combination with other antiretrovirals or alone for the treatment of HIV-1 infection. Lupin was the first applicant to file an ANDA for Trizivir tablets and as such will be entitled to 180 days of marketing exclusivity.

Trizivir tablets, 300 mg (base)/150 mg/300 mg had annual US sales of approximately $111.6 million, as per IMS MAT Sept. 2013 data.

 
[Close]