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27 May 2011

Teva's Generic Combivir Tablets Approved for Launch

The FDA has determined that Teva is eligible for a 180-day period of marketing exclusivity for Combivir Tablets.

Teva Pharmaceutical Industries Ltd. announced yesterday that the FDA has granted approval for the Company's Abbreviated New Drug Application (ANDA) to market a generic version of ViiV Healthcare Company's HIV treatment, Combivir Tablets (Lamivudine and Zidovudine).


Shipment is expected to commence during the fourth quarter 2011, as per the terms of a settlement agreement between Teva and Glaxo Group Ltd. and ViiV Healthcare.


The brand product had annual sales of approximately $315 million in the United States, based on IMS sales data.


As the first company to file an ANDA containing paragraph IV certification for these products, the FDA has determi

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