Aurobindo Pharma gets approval for Efavirenz Tablets

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Aurobindo Pharma gets approval for Efavirenz Tablets

Aurobindo Pharma Limited is pleased to announce that it has received the tentative approval to manufacture and market Efavirenz Tablets 100mg from the US Food & Drug Administration

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Aurobindo Pharma Limited is pleased to announce that it has received the tentative approval to manufacture and market Efavirenz Tablets 100mg from the US Food & Drug Administration (USFDA).

The New Drug Application (NDA) 22-297 provides for the use of Efavirenz Tablets 100mg in combination with other antiretrovirals agents and is indicated for the treatment of HIV infections.

The company had earlier received tentative approvals to Efavirenz Tablets 600mg, Efavirenz Capsules 50, 100 and 200 mg and Co-Packaged Lamivudine / Zidovudine Tablets & Efavirenz Tablet 150 mg / 300 mg & 600 mg

This is Aurobindo's 86th ANDA approval from USFDA (61 Final approvals, 25 Tentative approvals). 

Sourced From: Aurobindo Pharma Limited