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I found the information below at various internet sites with the majority at http://www.ashp.org/import/news/HealthSystemPharmacyNews/newsarticle.aspx?id=3 097
I believe that Creon has now been approved by the FDA.
Pancreatic enzyme products have been available in the United States since before the 1938 passage of the Food, Drug, and Cosmetic Act. FDA in 2004 declared pancreatic enzyme products new drugs that required formal agency approval. The agency has given manufacturers until April 2010 to obtain marketing approval of their pancrelipase products.
At least three other manufacturers in addition to Solvay have publicly announced that they are seeking FDA approval for pancrelipase preparations: Axcan, the Canadian manufacturer of the Ultrase line of pancrelipase products; Bethlehem, Pennsylvania-based Digestive Care Inc., which is seeking to market Pancrecarb; and Amsterdam-headquartered Eurand N.V., which has filed for the approval of Zentase
Robert Kuhn, associate director of pharmacy services at the Kentucky Children's Hospital in Lexington, said he has been waiting for years for well-characterized, FDA-approved pancrelipase products to become available. 'This will clear up the whole issue of whether you can substitute these drugs or not,' said Kuhn, who practices at the hospital's Cystic Fibrosis Foundation-accredited patient care center.
FDA, in explaining its decision to regulate pancrelipase preparations, cited the need to standardize the enzyme activity of the products. The agency's decision was also influenced by reports of treatment failures and adverse events among patients whose usual regimen had been switched to so-called generic pancrelipase products.
No pancrelipase preparation sold in the United States has ever been designated therapeutically equivalent to another pancrelipase product. Kuhn noted that state Medicaid formularies have sometimes required the substitution of so-called generics for branded pancrelipase products. He speculated that the availability of the FDA-approved Creon will put an end to such forced substitutions.
Pancrelipase is lipase, protease and amylase which has been extracted from pig pancreas. If you look at the Creon summary below, you will find that the dosage of each enzyme varies as the capsule progresses from Creon 6 (equates to 6,000 USP units of lipase) to Creon 24 (equates to 24,000 USP units of lipase). The price per USP unit seems to be a little lower as dosage increases.
• Capsules: 6,000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase capsules have an orange opaque cap with imprint “CREON 1206” and a blue opaque body. (3)
• Capsules: 12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase capsules have a brown opaque cap with imprint “CREON 1212” and a colorless transparent body. (3)
• Capsules: 24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase capsules have an orange opaque cap with imprint “CREON 1224” and a colorless transparent body.
Here is a price list from CF Services Pharmacy. It was the first to pop up on a Google for prices. It turns out that Cystic Fibrosis patients need the enzymes also.
Ultrase caps 100 $71.07 Ultrase MT-12 caps 100 $147.67 Ultrase MT-18 caps 100 $244.48 Ultrase MT-20 caps 100 $271.72 Pancrecarb MS -8 caps 100 $164.60 Pancrecarb MS –16 caps 100 $307.50 Pancrecarb MS-4 caps 100 $90.90 Pancrease MT-10 caps 100 $122.05 Pancrease MT-16 caps 100 $195.95 Pancrease MT-20 caps 100 $244.04 Pancrease MT-4 caps 100 $48.82 Creon 12 caps 100 $157.84 Creon 24 caps 100 $290.08 Creon 6 caps 100 $84.54 Zenpep 15 caps 100 $189.97 Zenpep 20 caps 100 $273.25 Zenpep 5 caps 100 $78.89
If I can be of any help to anybody, please do not hesitate to say something. You won't have to ask. I will volunteer. I am glad to still be alive.
DOB: Jan 08, 2010 Location: Johns Hopkins Attending physician: Dr Tim Pawlik
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