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| Aurobindo Pharma receives tentative approval for its New Drug Application (NDA) Abacavir Sulfate / Lamivudine Tablets 60/30mg | |||
| 23 Dec 2008
: 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). About Aurobindo Pharma Limited: Aurobindo Pharma Limited (www.aurobindo.com), headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. The company’s robust product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics, supported by an outstanding R&D set-up. The Company is marketing these products globally, in over 100 countries.. |
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