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Aurobindo gets approval for Abacavir Sulfate/Lamivudine tab
Aurobindo Pharma Limited is pleased to announce that it has received the tentative approval to manufacture and market fixed dosed combination Abacavir Sulfate / Lamivudine Tablets 60/30mg from the US Food & Drug Administration
Aurobindo Pharma Limited is pleased to announce that it has received the tentative approval to manufacture and market fixed dosed combination Abacavir Sulfate / Lamivudine Tablets 60/30mg from the US Food & Drug Administration (USFDA).
The New Drug Application (NDA) 22-295 provides for the use of Abacavir Sulfate / Lamivudine Tablets 60/30mg for the treatment of HIV infections.
The company had earlier received tentative approvals to Co-Packaged Lamivudine / Zidovudine Tablets + Abacavir Sulfate Tablets 150/300mg + 300mg and Abacavir Sulfate / Lamivudine Tablets 600/300 mg
This is Aurobindo's 87th ANDA approval from USFDA (61 Final approvals, 26 Tentative approvals).