Biotech Values

[jq1234]

Bayer Joins the Combo Drug NCE Challenge Club; Petitions FDA for 5-Year Exclusivity for NATAZIA

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/05/bayer-joins-the-combo-drug-nce-challenge-club-petitions-fda-for-5-year-exclusivity-for-natazia-.html?utm_source=twitterfeed&utm_medium=twitter

the company asks the Agency to effectively erase the award of 3-year new clinical investigation exclusivity for the oral contraceptive NATAZIA (estradiol valerate and estradiol valerate/dienogest) Tablets and instead award a period of NCE exclusivity. Similar requests for NCE exclusivity recognition were made in petitions submitted to FDA earlier this year concerning STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) Tablets (Docket No. FDA-2013-P-0058) and PREPOPIK (sodium picosulfate, magnesium oxide and citric acid) for Oral Solution (Docket No. FDA-2013-P-0119). Indeed, the STRIBILD petition called out NATAZIA as one example for which NCE exclusivity would be ongoing if FDA had awarded such exclusivity in the first place.