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FOOD AND DRUG ADMINISTRATION - page 191 / 263

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before.  Unaccountable or stability overages were viewed as unacceptable and would prevent the approval of that product.

Between June 1999 and July 2001, nine sponsors submitted stand-alone NDA applications.  The first product was approved in August of 2000.  There are currently six approved levothyroxine sodium tablet NDAs, and I have them listed here.  We've got Lloyd, Jerome Stevens, Genpharm, Jones, MOVA, and Abbott Pharmaceuticals.

I'd like to conclude by saying that the process that I've just described has had a major impact in improving the quality and consistency of these six FDA-approved products.  Important issues, such as overages, content uniformity, and bioavailability, have been addressed, and product-specific dissolution tests ‑‑ I'll repeat that again because it's very important ‑‑ product-specific dissolution tests have been conducted.  And it's very important that these were specific to the product because it allows for lot-to-lot consistency and quality evaluation.

These steps go a long way in addressing some

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