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8 May 2019 Tablets & Capsules the year, the agency successf ully implemented many of the provisions in GDUFA II and the FDA Reautho- r ization Act of 2017 (F DA R A). These provisions included requests for pr e-A bbr eviated New D r u g Applic at ion (A N DA) me et ing s, reconsideration requests, one-time marketing stat us upd ates to the "Orange Book," and competitive generic therapy designation and exclusivity requests. The FDA also approved or tentatively approved 1,021 ANDAs and published more than 250 new or revised guidances, product-specif ic g uid ances, and manuals of policies and procedures for stakeholders. The full report can be accessed at www.fda.gov/Drugs/ ResourcesForYou/Consumers/Buyin g U s in g M e d i c in e S a f el y/ G e n e r i c Drugs/ucm631710.htm. Briefly noted… The FDA approved Jatenzo (tes- tosterone undecanoate), an oral tes- tosterone capsule to treat men with certain forms of hypogonadism. It is manufactured by Clarus Therapeu- tics, Northbrook, IL. The agency approved Mayzent (siponimod) as a treatment for adults with relapsing forms of multiple scle- rosis. The tablet product is manufac- tured by Novartis, Basel, Switzerland. T he FDA approved a generic form of Novartis' Diovan (valsartan), an angiotensin II receptor blocker that treats high blood pressure and heart failure. The generic is manu- fact ured by Alkem L aboratories, Mumbai, India. The agency also approved four generics for Letairis (ambrisentan), a treatment for pulmonar y arterial hypertension. The generic approvals were granted to Mylan Pharmaceu- t ics, Watson L aborator ies, S u n Pharma Global, and Zydus Pharma- ceuticals. The original brand-name product is manufactured by Gilead, Foster City, CA. s e ss ment aud it s for the G loba l Retailer and Manufacturer Alliance (G R M A) st and ard s. E arlier this year, the GR M A announced the publication of NSF/ANSI 455, a set of consensus-based GMP auditing s t and a r d s for manu f ac t u r e r s of d ietar y s upplements, cosmet ics, personal-care products, and over- the-counter dr ugs, to reduce the number of audits and the associated costs of auditing to multiple inde- pendent standards. GR MA trained NSF's auditors to conduct interim gap audits, and the auditors will eventually provide certification to the GR MA manufacturing quality system standards. OGD approves more than 1,000 ANDAs in 2018 ROCKVILLE, MD—The Office of Generic Drugs (OGD) published its Annual Report for 2018, the first year the Generic Dr ug User Fee A m e n d m e n t s R e a u t h o r i z a t i o n (GDUFA II) was in effect. During cology Considerations," provides rec- ommendations to sponsors planning to conduct food-effect studies for orally administered drug products as part of INDs, NDAs, and supple- ments to these applications. IPEC-Americas publishes DMF FAQs A R L I N G T O N , VA — I P E C - Americas volunteers recently added a frequently asked questions (FAQs) annex to the 2018 Excipient Master File Guide, which was reissued in 2019. The annex answers the 15 most common questions asked by excipient manufacturers regarding excipient Drug Master Files (DMF) (Type IV). The guide can be down- loaded for free at ipecamericas.org/ reference-center/document-depot. NSF International provides GRMA pre-assessment audits ANN ARBOR, MI—NSF Inter- national, an independent public health and safet y organizat ion, now offers interim gap or pre-as- When you really need to know the flow of your POWDER... PFT ™ Powder Flow Tester IDEAL FOR MANUFACTURERS who process powders daily and have flow problems with bins, hoppers, silos and feeders QUICK & EASY ANALYSIS of flow behavior using proven shear cell test method UNIVERSITY DISCOUNT Available in USA – call for details TEL 800-628-8139 or 508-946-6200 www.belusa.com