Biznes · 12.07.20211 min czytania
Morton Grove Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 21 Abbreviated New Drug Applications; Correction
Automatyczne tłumaczenie lokalne · Oryginalny język źródła
Streszczenie
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of December 2, 2019. The document announced the withdrawal of approval of 21 abbreviated new drug applications (ANDAs) from multiple applicants, effective January 2, 2020. The document erroneously included ANDA 076709 for Fentanyl Extended-Release Film, 25 micrograms (mcg)/hour (hr), 50 mcg/hr, 75 mcg/hr, 100 mcg/hr, held by Actavis Laboratories UT, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 577 Chipeta Way, Salt Lake City, UT 84108, and ANDA 077062 for Fentanyl Extended-Release Film, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, and 100 mcg/hr, held by Mayne Pharma LLC, 1240 Sugg Parkway, Greenville, NC 27834. This correction is being made because FDA previously withdrew the approval of ANDAs 076709 and 077062 in the Federal Register of November 18, 2019. This notice corrects that error.