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Home » FDA Publishes 28 New Product-Specific BE Guidances
FDA Publishes 28 New Product-Specific BE Guidances
January 7, 2015
The FDA published 28 new product-specific guidances and revised testing recommendations on another 15 therapies to aid ANDA filers in designing bioequivalence studies for their applications.
In total the FDA now has 1,236 product-specific guidances with BE study recommendations.
The new additions include those for Ulesfia (benzyl alcohol), Stribild (cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate), Aczone (dapsone), Latuda, (lurasidone HCL) and Stivarga (regorafenib), Xeljanz (tofacitinib citrate).
Revised BE guidances include those for Epiduo (adapalene; benzoyl peroxide), Bystolic (nebivolol HCL), Renvela (sevelamer carbonate) and Renagel (sevelamer HCL).
