Issue link: https://www.e-digitaleditions.com/i/1349974
Tablets & Capsules March/April 2021 9 well as those with relapsed or refractory follicular lymphoma who have received at least three prior lines of systemic therapy. The product is manufactured by TG Therapeutics, New York, NY. The agency also approved Tepm- etko (tepotinib) to treat adult patients with metastatic non-small-cell lung cancer harboring mesenchymal-ep- ithelial transition exon 14 skipping alterations. The approval was granted to EMD Serono, Rockland, MA. of cancerous cells in dogs. It is the first conditionally approved oral treat- ment for dogs with lymphoma. The product is manufactured by Anivive Lifesciences, Long Beach, CA. Briefly noted… The FDA granted accelerated approval of Ukoniq (umbralisib), a treatment for adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen as ISPE publishes maintenance guide NORTH BETHESDA, MD—The International Society for Pharmaceutical Engineering (ISPE) has published the second edition of the ISPE Good Practice Guide: Maintenance, which describes the current established good practices and provides a practical and consistent inter- pretation of the required elements of a pharmaceutical maintenance program. The updated guide includes consolidated basic and good practices categories, added clarification on terminology, and updated examples. The content of the second edition is aligned with the ICH Q9 risk-based approach with respect to maintenance and the industry as a whole. The guide can be purchased at ispe.org/ publications/guidance-documents. FDA approves first oral therapy for lupus nephritis SILVER SPRING, MD—The FDA approved Lupkynis (voclosporin) in combination with a background immu- nosuppressive therapy regimen to treat adult patients with active lupus nephri- tis. This is the first FDA-approved oral drug for the treatment of this condition. The product is manufactured by Aurinia Pharmaceuticals, Victoria, BC. IPEC publishes revised general glossary ARLINGTON, VA—The Inter- national Pharmaceutical Excipients Council Federation (IPEC Federation) has published a revised edition of the IPEC General Glossary of Terms and Acronyms for Pharmaceutical Excipients. The glossary was originally published in 2014 and has been used to define excipi- ent terms and acronyms commonly found in IPEC guides. The revised guide can be downloaded at https://ipecamericas. org/reference-center/document-depot. FDA conditionally approves first oral treatment for canine lymphoma SILVER SPRING, MD—The FDA granted conditional approval of Laver- dia-CA1 (verdinexor) tablets as a treatment for dogs with lymphoma. The drug prevents certain proteins from leaving the nucleus of cancer cells, allowing these proteins to con- trol the growth and prevent the spread RELIABLE MEASUREMENT OF SINGLE AND MULTI-TIP PUNCHES Reduce the labor-intensive process of measuring and recording tablet tooling measurements with IPR's new TIAS MTL40. Precision linear stages and laser sensor technology provide quick, accurate and repeatable non-contact measurement. IPRINC.NET recording tablet tooling measurements RELIABLE MEASUREMENT OF SINGLE AND MULTI-TIP Reduce the labor-intensive process of measuring and recording tablet tooling measurements RELIABLE MEASUREMENT OF SINGLE AND MULTI-TIP Reduce the labor-intensive recording tablet tooling measurements RELIABLE MEASUREMENT OF SINGLE AND MULTI-TIP PUNCHES Reduce the labor-intensive process of measuring and recording tablet tooling measurements with IPR's new TIAS MTL40. Precision linear stages and laser sensor FAST, ACCURATE AND FAST, ACCURATE AND FAST, ACCURATE AND FAST, ACCURATE AND FAST, ACCURATE AND FAST, ACCURATE AND TOOLING INSPECTION SYSTEM