NME Exclusivity Petitions Expand; Ferring Request For Colon-Cleansing Combo Has Urgency
Ferring requests five years of marketing exclusivity for Prepopik; Gilead also has asked FDA to award five years of exclusivity for active ingredients in a combination product that has not been previously approved, but Gilead has patents to fall back on while Ferring has none.
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FDA rejects requests by firms to make new policy retroactive; Gilead’s Harvoni and Eisai’s Akynzeo fixed combos, approved the day FDA issued its final guidance, granted exclusivity.
In response to citizen petitions from Gilead, Ferring and Bayer, FDA issued a draft guidance saying future fixed-combination products that include a previously approved active moiety will be eligible for five years of new chemical entity marketing exclusivity.
FDA warns that use of aliskiren-containing blood pressure drugs with ACE inhibitors or angiotensin receptor blockers may increase risk of kidney impairment, hypotension and hyperkalemia; Novartis to continue to sell four other aliskiren products.