[paula_w]

Is this Pharma learning the hard way?

From Fierce Biotech
IMPAX Laboratories Receives FDA Non-Approvable Letter for Vadova(R); Company Considering Options
1/30/2008

HAYWARD, Calif.--(BUSINESS WIRE)--IMPAX Laboratories, Inc. (OTC:IPXL - News) today announced that it has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) concerning its new drug application (NDA) and subsequent submissions for Vadova® (carbidopa/levodopa extended release) tablets. The FDA’s action was primarily based on unresolved issues relating to product nomenclature and its belief of a likelihood of medication errors resulting from confusion of Vadova with other marketed forms of carbidopa/levodopa.

The NDA, which was originally filed in April 2005, was deemed non-approvable in March 2006. IMPAX subsequently filed responses addressing the FDA’s earlier concerns, which included clinical pharmacology and chemistry, manufacturing and control components. These concerns were not cited in the most recent non-approvable letter.

“We are very disappointed with the receipt of this letter, and we continue to believe that Vadova represents a significant improvement in the choices available to patients in the treatment of the symptoms of Parkinson’s disease,” said Larry Hsu, Ph.D., president and chief executive officer of IMPAX Laboratories. “We will continue to pursue discussions with the FDA concerning this decision and we are evaluating all options for the product.”



About IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division and markets its branded products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com [1]. "


paula

[ZucchiniFlower]

Paula, is there another extended release formulation that is available now?

The reason the FDA gave doesn't make much sense to me. Why would that reason not apply to all extended release formulations of other drugs.....fear of confusion? I don't get it.

[paula_w]

ZF,

just the sinemet CR and it's generic, as far as I know. I wonder if they are thinking this is too much the same? I really don't know either, maybe someone from the FDA can explain it at PAN is this weekend I'll try to remember to ask.

paula

[ol'cs]

“We are very disappointed with the receipt of this letter, and we continue to believe that Vadova represents a significant improvement in the choices available to patients in the treatment of the symptoms of Parkinson’s disease,” said Larry Hsu, Ph.D., president and chief executive officer of IMPAX Laboratories. “We will continue to pursue discussions with the FDA concerning this decision and we are evaluating all options for the product.”

Makes me sick, i just wanna puke
It's not even a "me too" drug. "Me too's are at least structurally similatr to a known anti-Parkinson, this is just (as said above) generic sinemet CR.

[lou_lou]

Source URL:
http://www.fiercebiotech.com/press-r...-letter-vadova

[lou_lou]

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[ZucchiniFlower]

New formulations of CoQ10 are better absorbed by the brain than older ones. I don't consider them "me too" drugs; they are welcome improvements. Maybe this company has better technology for Sinemet:

Proprietary Technologies

Concentric Multiple-Particulate Delivery System (CMDS)
US Patent 5,885,616
Many of today’s controlled-release technologies are designed for the release of only one active ingredient with one rate of release. This release profile may not be adequate for drugs in certain therapeutic categories. Our CMDS technology is designed to control the release rate of multiple active ingredients in a multi-particulate dosage form. This technology allows us to overcome one of the technical challenges in the development of multi-particulate dosage forms – achieving acceptable uniformity and reproducibility of a product with a variety of active ingredients. Our CMDS technology is designed to allow for the release of each of the active ingredients through an encapsulated form at predetermined time intervals and desired levels on a consistent basis.

Timed Multiple-Action Delivery System (TMDS)
US Patent 6,372,254
Similar to CMDS, this system controls release rates for multiple ingredients within a single table in a programmed manner. Our TMDS technology allows for the release of more than one active ingredient in a single tablet formulation to be released in multiple profiles over time.

Dividable Multiple-Action Delivery System (DMDS)
US Patent 6,602,521
Our proprietary DMDS system is an extension of our CMDS and TMDS technologies. It is designed to provide greater dosing flexibility which improves product efficacy and reduces side effects. Traditional controlled-release tablets often lose their “controlled” mechanism of delivery once broken. Our DMDS technology allows the tablet to be broken in half so that each respective portion of the tablet will achieve exactly the same release profile as the whole tablet. This allows the patient and physician to adjust the dosing regimen according to the clinical needs without compromising efficacy.

Particle Dispersion Systems (PDS)
US Patent 6,531,158
One of the challenges in the formulation of an insoluble drug is to achieve satisfactory bioavailability in humans. Our proprietary PDS system provides a drug delivery system for the oral administration of water insoluble inactive ingredients.

Pharmaceutical Stabilization System (PSS)
US Patent 6,333,332
Our PSS system is designed to create an acidic micro-environment for drugs which require an acidic environment to achieve optimal stability. We achieve this environment through the addition of an organic acid using several salts which retard the degradation of, and therefore stabilize, certain active ingredients.

Programmed Multiple-action Delivery System (PMDS)
Our PMDS technology is designed to provide for the multi-phasic delivery of any active ingredient in a more controlled fashion as compared to typical controlled release technologies. Our PMDS technology is designed to allow for the release of the active ingredient at predetermined time intervals and desired levels on a consistent basis. This technology allows us to overcome one of the technical challenges in the development of multi-particulate dosage forms – achieving acceptable uniformity and reproducibility of a product with a variety of release rates. It is designed to provide greater dosing flexibility that improves product efficacy and may reduce side effects. We expect to file a patent application for PMDS with the USPTO.

Multi-ingredient Multiple-Action Delivery System (MMDS)
Similar to PMDS, this system provides multi-phasic delivery of two or more different active ingredients within a single tablet. Our MMDS technology allows for the release of more than one active ingredient in a single tablet formulation to be released in multiple profiles over time in a more controlled fashion as compared to typical controlled release technologies. We expect
to file a patent application for MMDS with the USPTO.

http://www.impaxlabs.com/proptech.php