Wednesday, April 2, 2014

Alfrezza Gets Approved Byfda: Long Awaited Victory For Mannkind!

Mannkind, after a long battle with the authorities, won the recommendation of FDA and U.S advisory panel for launching its product Alfrezza into the market. Alfrezza is a drug for the treatment of Type 1 and Type 2 diabetes.

This insulin that can be inhaled is different and more effective than Pfizer’s first product as it works even faster than the injections and is very similar to the insulin that the healthy people can produce naturally in their bodies, as a stated in the News On wellness.

The recent voting by the Food and Drug Administration has approved Afrezza for both Type 1 and Type 2 diabetes even though it had rejected it earlier for type 1 diabetes. There was an uncertainty regarding the approval of the drug for type 1 as it has been reported before to cause lung infection. A number of missing reports on the same had raised suspicion in many members of FDA.

It is a big victory for Mannkind as it has been almost eight years that the company had been trying to get its drug approved. It sales had fallen drastically owing to the fact that Pfizer Inc had to withdraw the inhaled insulin, the only of its kind, from market and Alfrezza had been rejected by the FDA a couple of times.

The sale estimate of this one, of its kind drug is extremely high. By 2018 it may generate more than $600 million. The FDA is yet to decide whether to approve the drug by April 15th this year.

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