Papain Topical Products

27 January 2009

Products Affected - Description

Papain / Urea Debriding Ointment
Accuzyme ointment 6 g (NDC 00064-1000-07), Healthpoint - discontinued
Accuzyme ointment 30 g (NDC 00064-1000-01), Healthpoint - discontinued
Allanzyme 650 ointment 30 g (NDC 13279-0100-30), Allan Pharmaceutical - discontinued
Ethezyme ointment 30 g (NDC 58177-0804-02), Ethex - discontinued
Ethezyme 650 ointment 30 g (NDC 58177-0868-02), Ethex - discontinued
Ethezyme 830 ointment 30 g (NDC 58177-0816-02), Ethex - discontinued
Kovia ointment 3.5 g (NDC 58980-0711-35), Stratus - discontinued
Kovia ointment 30 g (NDC 58980-0711-11), Stratus - discontinued

Papain / Urea Debriding Spray
Accuzyme spray 30 mL (NDC 00064-1001-33), Healthpoint - discontinued
Accuzyme SE spray 34 mL (NDC 00064-1001-34), Healthpoint - discontinued
Allanzyme spray 33 mL (NDC 13279-0102-33), Allan Pharmaceutical - discontinued

Papain / Urea Debriding Foam
Paptase foam 45 g (NDC 16781-0175-45), Onset Therapeutics - discontinued

Papain / Urea / Chlorophyllin copper complex sodium Debriding Ointment
Allanfil 405 ointment 30 g (NDC 13279-0101-30), Allan Pharmaceutical - discontinued
Panafil ointment 6 g (NDC 00064-3410-07), Healthpoint - discontinued
Panafil ointment 30 g (NDC 00064-3410-30), Healthpoint - discontinued
Ziox 405 ointment 3.5 g (NDC 58980-0776-35), Stratus - discontinued
Ziox 405 ointment 30 g (NDC 58980-0776-11), Stratus - discontinued

Papain / Urea / Chlorophyllin copper complex sodium Debriding Spray
Allanfil spray 33 mL (NDC 13279-0103-33), Allan Pharmaceutical - discontinued
Panafil spray 33 mL (NDC 00064-3510-33), Healthpoint - discontinued
Panafil SE spray 34 mL (NDC 00064-3510-34), Healthpoint - discontinued

Reason for the Shortage

• Ethex has discontinued their Ethezyme products. The company would not provide a reason for the discontinuation.
• Papain topical products are unapproved drugs. The Federal Register has announced that the Food and Drug Administration (FDA) will require companies to file a New Drug Application (NDA) or an Abbreviated NDA to market topical papain products. FDA will take enforcement action against any company introducing new topical papain products after September 22, 2008, and against any company marketing currently-available topical papain products manufactured after November 23, 2008 or shipping such products after January 20, 2009. http://edocket.access.gpo.gov/2008/pdf/E8-22300.pdf

Estimated Resupply Dates

Papain topical products that were previously marketed in the US may not be manufactured after November 23, 2008 or shipped after January 20, 2009, according to FDA.

Updated

January 27, 2009; November 19, 2008; September 29, 2008, University of Utah, Drug Information Service.

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