Aurobindo Pharma today said it has recieved a tentative New Drug Approval from USFDA for its fixed dose combination product used for treating HIV-1 infection.
The new drug approval is for fixed dose combination drug product containing Lamivudine, Zidovudine, Nevirapine tablets used in the treatment of HIV-1 infection, the company informed the Bombay Stock Exchange.
AdvertisementThe three drugs would now be available in one single tablet and the company is the sole manufacturer of this approved combination, it said, adding that this is the first NDA generic approval for a three-drug combination.
These three drugs have a market of 4.5 billion dollars worldwide and the usage of the drugs is growing due to the outstanding commitment of the US government in particular and the WHO to rehabilitate HIV patients, the company said adding, that with the approval its ARV product portfolio has increased to 15 including two NDA approvals.
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