Tuesday 17 June, 2008

Drug approvals: venlafaxine (Mylan), Irbesartan and Hydrochlorothiazide (Mylan), Escitalopram (Lupin)

Mylan got Final Approval for Venlafaxine Hydrochloride, Irbesartan and Hydrochlorothiazide
Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received final approval from the USFDA for its ANDA for Venlafaxine Hydrochloride (HCl) Tablets 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base) and 100 mg (base).

Mylan got tentative Approval for Avalide (Irbesartan and Hydrochlorothiazide )Tablets
Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received tentative approval from the USFDA for its ANDA for Irbesartan and Hydrochlorothiazide Tablets, 150 mg/12.5 mg and 300 mg/12.5 mg


Lupin Receives USFDA Approval for Escitalopram Oxalate Tablets
Lupin announced that it has received tentative approval for the company's Abbreviated ANDA for Escitalopram Oxalate Tablets 10 mg and 20 mg from the USFDA

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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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