FDA Slaps Fenofibrate's Impax With Warning; CA Factory Affected

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Main Category: Pharma Industry / Biotech Industry
Article Date: 07 Jun 2011 - 3:00 PDT


Impax Laboratories with 93 manufactured products which represent dosage variations of 29 different pharmaceutical compounds got a slap on the wrist by the U.S. Food and Drug Association (FDA) this week in the form of a warning letter related to an inspection of their Hayward, California factory.

Deviations cited were related to sampling and testing of in process materials and drug products, production record review and Impax's process for investigating the failure of certain manufacturing batches to meet specifications. These inspection flaws lead to a recall of Fenofibrate earlier in the year; March to be more specific.

Fenofibrate helps reduce cholesterol and triclygerides in the blood. High levels of these types of fat in the blood are associated with an increased risk of atherosclerosis (clogged arteries). It is also used to treat high cholesterol and high triglyceride levels. It is used in combination with a diet low in cholesterol and saturated fat.

Larry Hsu, Ph.D., president and CEO, Impax Laboratories stated:

"Impax remains committed to providing the highest quality products to our customers and working with the FDA to diligently resolve any issues. We intend to promptly respond to the FDA's letter, and have already begun to implement changes and establish procedures that address the observations cited during the inspection. We will work diligently to remedy any outstanding issues in a timely manner. We don't anticipate that this manufacturing setback will delay our ongoing research and development activities. We expect to continue to develop our generic pipeline of 82 products and two brand products."

The warning letter did not place restrictions on the Company's ability to manufacture and ship product. While during the past three months, the production level at the Hayward facility was reduced to implement several key changes in the Company's quality system, the Company is now producing product at a normal pace and does not currently plan to reduce its product manufacturing or hold shipments of finished product.

GlaxoSmithKline and Impax pharmaceuticals are also co-developing a drug for the treatment of Parkinson's disease and also collaborating in its subsequent marketing. The drug under spotlight is the cardiopa-lovodopa drug manufactured by Impax.

Levodopa is converted to dopamine via the action of a naturally occurring enzyme called DOPA decarboxylase. This occurs both in the peripheral circulation and in the central nervous system after levodopa has crossed the blood brain barrier. Activation of central dopamine receptors improves the symptoms of Parkinson's Disease, however, activation of peripheral dopamine receptors causes nausea and vomiting.

For this reason levodopa is usually administered in combination with a DOPA decarboxylase inhibitor (DDCI), in this case carbidopa, which is very polar (and charged at physiologic pH) and cannot cross the blood brain barrier, however prevents peripheral conversion of levodopa to dopamine and thereby reduces the unwanted peripheral side-effects of levodopa. Use of carbidopa also increases the quantity of levodopa in the bloodstream that is available to enter the brain.

Also in a news release from Impax, they state they will play along and do their best to resolve this issue:

"The Company will continue to work to fully address the FDA's concerns and to resolve these issues. The Company will respond to the FDA's warning letter within the mandated 15 business day response period."

Sources: Impax and The Stock Market Watch

Written by Sy Kraft


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