{"id":408641,"date":"2021-01-05T09:06:23","date_gmt":"2021-01-05T14:06:23","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=408641"},"modified":"2021-01-05T09:06:23","modified_gmt":"2021-01-05T14:06:23","slug":"fda-extends-shelf-life-of-octapharmas-cutaquig-16-5-for-adult-pi-patients","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-extends-shelf-life-of-octapharmas-cutaquig-16-5-for-adult-pi-patients\/","title":{"rendered":"FDA Extends Shelf Life of Octapharma\u2019s cutaquig\u00ae 16.5% for Adult PI Patients"},"content":{"rendered":"

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FDA Extends Shelf Life of Octapharma\u2019s cutaquig\u00ae<\/sup> 16.5% for Adult PI Patients<\/b><\/p>\n

As concerns about the supply of immunoglobulin rise, FDA extends expiration date for certain existing lots already in distribution and all new lots of Octapharma\u2019s SCIg<\/i><\/p>\n

PARAMUS, N.J.–(BUSINESS WIRE<\/a>)–Octapharma USA<\/span><\/a> today announced the U.S. Food & Drug Administration<\/span><\/a> (FDA) has extended the expiration date of 42 existing lots of cutaquig<\/span><\/a>\u00ae<\/sup> [Immune globulin, Subcutaneous (Human)-hipp, 16.5% Solution] that are currently in the distribution chain. The FDA decision extends the shelf life of all future lots of cutaquig\u00ae<\/sup> from 24 to 36 months when stored at 2\u00b0C to 8\u00b0C (36\u00b0F to 46\u00b0F). The six-month shelf life of cutaquig\u00ae <\/sup>stored at room temperature up to +25 \u00baC (77\u00baF) remains unchanged.\n<\/p>\n

This press release features multimedia. View the full release here: https:\/\/www.businesswire.com\/news\/home\/20210105005155\/en\/<\/a><\/p>\n

\"Octapharma<\/p>\n

Octapharma USA today announced the U.S. Food & Drug Administration (FDA) has extended the expiration date of 42 existing lots of cutaquig\u00ae [Immune globulin, Subcutaneous (Human)-hipp, 16.5% Solution] that are currently in the distribution chain. The FDA decision extends the shelf life of all future lots of cutaquig\u00ae from 24 to 36 months when stored at 2\u00b0C to 8\u00b0C (36\u00b0F to 46\u00b0F). The six-month shelf life of cutaquig\u00ae stored at room temperature up to +25 \u00baC (77\u00baF) remains unchanged.<\/p>\n<\/div>\n

\n\u201cThe FDA extension is great news for adult primary immune disease patients concerned about the available supply of immunoglobulin products,\u201d said Octapharma USA<\/span><\/a> President Flemming Nielsen. \u201cAs the supply of immunoglobulin products faces challenges in the near future, the longer shelf life of cutaquig<\/span><\/a>\u00ae<\/sup> is an important consideration. Octapharma has increased its production of immunoglobulin products by more than 45 percent over the last year so we have strong supply to meet patient needs.\u201d\n<\/p>\n

\nThe FDA has approved an extension of the expiration date for cutaquig<\/span>\u00ae<\/sup> from 24 to 36 months when stored at +2\u00b0C to +8\u00b0C (36\u00b0F to 46\u00b0F). The selected cutaquig<\/span>\u00ae<\/sup> lots, which are listed at fda.gov<\/span><\/a>, were all manufactured and distributed in 2019 and 2020. The six-month shelf life for cutaquig<\/span>\u00ae<\/sup> stored at room temperature up to +25\u00b0C (77\u00b0F) is unchanged. Future lots of Octapharma\u2019s subcutaneous immunoglobulin (SCIg) will be labeled according to the new dating period.\n<\/p>\n

About cutaquig\u00ae<\/sup><\/span><\/i><\/b><\/p>\n

\nCutaquig\u00ae<\/sup> (Immune Globulin Subcutaneous (Human) – hipp) is a 16.5% immune globulin solution for subcutaneous infusion indicated for treatment of primary humoral immunodeficiency (PI) in adults.\n<\/p>\n

WARNING: THROMBOSIS <\/b><\/p>\n