Perrigo (PRGO) Receives Tentative FDA Approval for its Clobetasol Propionate Topical Foam
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The Perrigo Company (Nasdaq: PRGO) announced that its Perrigo Israel Pharmaceuticals subsidiary has been granted tentative approval from the U. S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Topical Foam, 0.05%.
The reference listed drug (Olux(R) Foam, 0.05%, Connetics Corporation) is subject to a period of patent protection. Perrigo filed its ANDA with a paragraph IV patent certification stating that the patent is invalid, unenforceable, or will not be infringed under this ANDA.
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