FDA Publishes 28 New Product-Specific BE Guidances

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).

See the full list of new and revised guidances here: www.fdanews.com/12-29-14-BE-Product-Guidances.pdf.  — Bryan Koenig