Saturday, January 22, 2011

Byetta (exenatide injection) approved by Health Canada for the treatment of type 2 diabetes

Jan. 17 - Eli Lilly Canada Inc. is pleased to announce the Health Canada approval of BYETTATM (exenatide injection) for the treatment of adults with type 2 diabetes. BYETTA is indicated for use as a combination therapy with metformin and / or a sulfonylurea to improve blood sugar control in adults with type 2 diabetes who have not achieved adequate glycemic control on maximally tolerated doses of these oral therapies in addition to diet and exercise.

Byetta is peptide with 39 aminoacids and is very effective in controlling the blood glucose levels and is approved in US also.

Novo Nordisk Intends to Appeal Adverse Ruling in Prandin (repaglinide) Patent Case

Jan. 19, 2011 - Today, Novo Nordisk announced that Judge Avern Cohn of the US District Court for the Eastern District of Michigan issued an adverse ruling in a patent litigation case regarding Novo Nordisk's US Patent No. 6,677,358. The district court ruled that the patent, which covers the combination use of repaglinide and metformin for the treatment of type 2 diabetes, is invalid and unenforceable based on obviousness and inequitable conduct.

The district court ruling is available with me. In case of your interest, you can email me at amit@lifelinehisar.com. I will send you the copy of judgement in a summarised manner.

Novo Nordisk markets repaglinide under the trade name Prandin® and a fixed dose repaglinide/metformin tablet under the trade name PrandiMet®.

Novo Nordisk may appeal this judgement in the federal circuit.

Dr. Reddy's and other four generic players got final approval for Pantoprazole Sodium Delayed-Released Tablets

Jan 20, 2011 - Dr. Reddy's Laboratories today announced that it has launched Pantoprazole Sodium Delayed-Released tablets (20mg and 40mg strengths), a bioequivalent generic version of Protonix® Tablets in the US market. The Food & Drug Administration (FDA) approved Dr. Reddy's ANDA for Pantoprazole Sodium Delayed-Released tablets on January 19, 2011.

Along with Dr. Reddy's, Mylan, Kudco, torrent and on other player got final approval for Pantoprazole DR tablets. This final approval is due to the expiry of product patent in US. Earlier, Sun pharma and Teva was having final approval for the product.

Pantoprazole Sodium Delayed-Released tablets had total U.S. sales of approximately $1.8 billion for the twelve months ending September 30, 2010 according to IMS Health. Both strengths of Dr. Reddy's Pantoprazole Sodium Delayed-Released tablets are available in 90 count bottles.