Issue link: https://www.e-digitaleditions.com/i/1173734
8 October 2019 Tablets & Capsules FDA to add five substances to compounding list SILV E R S PR I NG , M D —T he FDA proposed an amendment to its 503A Bulks List regulations to add five substances to the list of bulk drug substances (APIs) that can be used in compounding despite not having applicable United States Pharmaco- peia (USP) or National Formulary (NF) monographs or being compo- nents of FDA-approved drugs. The proposed amendment also identifies 26 bulk drug substances that the FDA has considered and proposes not to include on the list. In other news, the agency will inactivate listing records in its data- base that have not been recently updated or certified or that include a company with an expired registra- tion. Drug listing records that have not been updated or certified can slow down surveillance operations for certain FDA programs. Up-to- date listing records are publicly avail- able in the FDA's National Dr ug Code Directory. Briefly noted… The FDA approved Ofev (nin- tedanib) to slow the rate of pul- monary function decline in adults with interstitial lung disease asso- c iat e d w it h s y s t e m i c s cle r o s is or scleroderma. Ofev is the first FDA-approved treatment for this rare lung condition and is manu- factured by Boehringer Ingelheim Pharmaceuticals. The agency also approved Kyowa Kirin's Nourianz (istradefylline) as an add-on treatment to levodopa/ carbidopa for adult patients with Parkinson's disease whose medica- tions are not working well, causing an increase in symptoms such as tremors and difficulty walking. AbbVie announced that the FDA approved Rinvoq (upadacitinib), a Janus kinase inhibitor that treats adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intol- erance to methotrexate. according to a joint EMA/FDA anal- ysis. The analysis compared the two agencies' decisions on 107 new med- icine applications from 2014 to 2016. In the 10 percent of cases where the agencies disagreed on an authoriza- tion decision, the cause was either differing conclusions on drug effi- cacy or differences in the clinical data submitted. This is the first anal- ysis by EMA and the FDA that com- pares the agencies' decisions on mar- keting authorizations. industry news EMA, FDA concur on most marketing authorization decisions for new drugs A MSTER DA M, Netherlands— The European Medicines Agency (EMA) and the FDA agree on more than 90 percent of marketing autho- rization decisions for new medicines, 嘀椀猀椀琀 甀猀 愀琀 䈀漀漀琀栀 㔀 ㈀ 一漀瘀⸀ ㌀ 㘀 ∠ 匀愀渀 䄀渀琀漀渀椀漀Ⰰ 吀攀砀愀猀 䠀攀渀爀礀 䈀⸀ 䜀漀渀稀愀氀攀稀 䌀漀渀瘀攀渀琀椀漀渀 䌀攀渀琀攀爀 倀䠀䄀刀䴀匀䌀䤀㌀㘀 䌀漀渀猀椀搀攀爀愀琀椀漀渀猀 昀漀爀 䐀攀瘀攀氀漀瀀洀攀渀琀 漀昀 吀眀漀 倀椀攀挀攀 䠀愀爀搀 䌀愀瀀猀甀氀攀 倀爀漀搀甀挀琀猀 吀甀攀猀搀愀礀Ⰰ 一漀瘀⸀ 㔀 㨀㌀ 愀⸀洀⸀ 倀愀爀琀渀攀爀 倀爀攀猀攀渀琀愀琀椀漀渀 䌀氀愀猀猀爀漀漀洀 Ⰰ 䔀砀栀椀戀椀琀 䠀愀氀氀 ㈀㌀㐀 匀瀀攀挀椀愀氀 瀀愀爀琀渀攀爀 瀀爀攀猀攀渀琀愀琀椀漀渀㨀