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FDA slaps vaginal gel maker for sloppy manufacturing, no NDA

Laclede criticized for not testing APIs in Luvena Prebiotic
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The FDA is again coming down on a California drugmaker for poor-quality manufacturing of an over-the-counter vaginal lubricant for yeast infections that the agency says needs to be treated as a prescription drug anyway.

In fact, the FDA says it has told Laclede of Rancho Dominguez, CA, several times now that as labeled, the Luvena Prebiotic needs to go through the new drug application process. The problems with the product and Laclede's manufacturing are detailed in a warning letter just posted to the FDA website.

As far as its manufacturing goes, the FDA says Laclede is not testing APIs used in Luvena Prebiotic such as lactoferrin, lactoperoxidase, lysozyme, D-mannose, and glycogen before the drugs are released. It rejected Laclede's contention that they were not APIs. It said the company has continued to manufacture and sell its product even after being informed of the problems in May last year. Additionally, the warning letter says, the company is not testing for potency and stability, so it can't determine expiration dates. The agency also criticized the manufacturer for not conducting "at least one specific identity test on a component" to see if its supplier's analysis of its API was valid.

The FDA told Laclede President Michael A. Pellico that Luvena needs approval as a combination product because it also involves an applicator. The agency also has problems with other products made by Laclede that it contends qualify as prescription drugs, including its "One Minute Topical Fluoride Foam" in strawberry and bubble gum flavors.

On top of all of its other responsibilities, the FDA must monitor legions of small manufacturers all over the world that are making products that they treat as OTC but which the agency says qualify as prescription products. Additional fees kicked in by API and generic drugmakers as part of the new PDUFA V program are intended to give the agency the money to get a better handle on manufacturers throughout the world. Those efforts have been slowed because of the budget sequestration, which is holding a big chunk of that money hostage. The White House has asked Congress to make changes to the laws so that the FDA can tap about $36 million in fees for the rest of the fiscal year, but so far that effort has gone nowhere. 

- here's the warning letter

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