Thursday 18 September, 2008

Drug approvals: Galantamine (Barr), Hydralazine (Hetero), Lamivudine and Tenofovir Disoproxil Fumarate (Matrix), Abacavir sulfate (Aurobindo)

1. Galantamine Hydrobromide Extended-Release Capsules 8 mg, 16 mg and 24 mg, Barr Lab got Final Approval (With FTF 180 days exclusivity), Earlier news of IPPharmdoc on this product Here
2. Hydralazine Hydrochloride Tablets, Hetero Drugs, Ltd., Approval
3. Keppra XR (levetiracetam) Extended-Release Tablets, UCB, Inc., Approval
4. Lamivudine and Tenofovir Disoproxil Fumarate Tablets, Matrix Laboratories, Ltd., (Tentative Approval)

5. Aurobindo Pharma has received the tentative approval to manufacture and market Abacavir sulfate tablets 60mg from the US Food & Drug Administration (US FDA). The company had earlier received tentative approvals to Abacavir sulfate tablets 300mg and Abacavir sulfate oral solution 20mg/mL.

Posted by ADKS at 10:10 am

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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