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Category: Legal
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Can you provide me the documentation that SARAPIN is FDA

Customer Question

Can you provide me the documentation that SARAPIN is FDA approved. How can I send you a letter from FDA to High Chemical Company about Sarapn not being "grandfathered " ?
Submitted: 11 months ago.
Category: Legal
Expert:  Briarcliff767 replied 11 months ago.
Hi it's not going to show in the database that it is approved due to it being approved before the actual laws took effect in 1932-1968. In 2006 there was a letter sent out to grandfathered companies that requested they get approval .
Customer: replied 11 months ago.
Please re-send me your initial response that SARAPIN is, indeed, FDA approved ! This is a big deal right now in America ! I hope you didn't mislead me !,,,,,
Expert:  Briarcliff767 replied 11 months ago.
I am not misleading you but give me till Monday to get the exact description for you because I have to get clearance to give you the information as it is classified
Expert:  Briarcliff767 replied 11 months ago.
I have to make sure that it is not in a clinical stage of approval with any manufacture because new drug application (NDA) under review is considered confidential and can only be disclosed to the drug sponsor as per 21 CFR 312.130 and 21 CFR 314.430, respectively.
Expert:  Briarcliff767 replied 11 months ago.
The only thing I can give you is straight from the FDA itself.Please be advised that the safety and efficacy claims for Sarapin have not been evaluated and approved by FDA.
The FDA website,, contains information regarding the drug approval process and the requirements for manufacturers of drug products.
The “Marketed Unapproved Drugs Compliance Policy Guide explains FDA’s policies aimed at ensuring that all drugs marketed in the U.S., prescription and over-the-counter, have been shown to be safe and effective. This guidance can be found on FDA’s webpage at Other related information can be found on, including resources for Heath Care Professionals to access to determine if a drug is FDA approved found at: Determining if a Drug is FDA Approved.
If a company claims that its drug is grandfathered, it is that company’s burden to prove that assertion as stated in the regulations at 21 CFR 314.200(e) Contentions that a drug product is not subject to the new drug requirements.Being cleared it grandfathered in does not stipulate an approval