USFDA gives provisional approval to Strides Arcolab’s HIV drug
USFDA gives provisional approval to Strides Arcolab’s HIV drug

On the guidelines of the paced-up review stipulations of the PEPFAR - President's Emergency Plant for AIDS Relief - the US Food and Drug Administration has given a provisional approval to HIV drug manufactured by the Bangalore-based global pharmaceutical company Strides Arcolab.

The new drug, which has recently received the FDA's tentative nod for treatment of AIDS, is a combination drug containing fixed doses of Lamivudine and Stavudine Tables 150 mg/130 mg, for a single application.

Noting that the recent FDA approval given to Strides Arcolab's HIV drug brings the total NDA's/ANDAs approvals under the PEPFAR program to eleven, V S Iyer, Strides Arcolab's Chief Executive Officer for India Operations, said: "This approval is yet another significant milestone in the front line of approvals for key HIV/AIDS medicines."

Iyer hailed the FDA decision on the proposed drug, and said that its approval "combined with our pipeline of second line drugs will make us a significant player in the quality, affordable multi-source ARVs business segment."

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