Active Ingredient: Hydroxyzine
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See United States v. Moreover, all of the Government experts stated that they themselves do not recognize Premo's products as safe and effective.
See Premo Pharmaceutical Laboratories v. United States, supra, at 803 " genuine dispute among qualified experts regarding a drug product's safety and effectiveness preclude its qualifying for exclusion as "generally recognized".
As to the remaining two Premo products, its allopurinol and triamterene with hydrochlorothiazide medications, the Government concedes that at least one is virtually identical to its pioneer counterpart.
Defendants contend that the final Premo product is also identical to its pioneer, but this is disputed by the Government. However, even assuming an identity of ingredients, qualitatively and quantitatively, between these two Premo products and their pioneers, the Government argues that 1 there is a potentially significant difference between the manufacturing processes used for one of the Premo products and its pioneer and between the two products' particle size, Government's Proposed Findings 153-54 sealed; and 2 with respect to the second Premo product there is no information available as to the particle size and source of Premo's active ingredient.
Government's Proposed Finding 205 sealed. The significant point here, of course, is not these differences themselves, both real and potential, but that, because of them, the Government witnesses have stated that there is no general expert recognition of the safety and efficacy of these two Premo products.
As to allopurinol, see P.
As to Premo's Triamthiazide, see P. United States, supra, at 805 n.
Nevertheless, I find the underlying logic of the Premo decision helpful on the issue. As defendants concede, differences in particle size and source of active ingredients can affect the safety and effectiveness of a drug product.
As defendants also concede, " ifferences in manufacturing techniques can affect the performance of a drug. United States at 8. See Findings of Fact 31-49.
Thus, there is a substantial question as to the safety and efficacy of Premo's products, which is one for FDA unless there is general expert recognition of the safety and effectiveness of the products and they have been used to a material extent or for a material time.
Here, again, however, there is no such general recognition; the testimony of the Government witnesses demonstrates, at the least, a "genuine difference of medical opinion among experts" and thereby precludes such a finding. Of these, only a few merit even brief attention at this juncture.