Alembic Pharmaceuticals Receives USFDA Final Approval for Levothyroxine Sodium Tablets
Alembic Pharmaceuticals Limited announced that it has secured final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Levothyroxine Sodium Tablets USP.The approved ANDA covers multiple strengths of the drug, including 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg.According to the company announcement, the approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Synthroid Tablets, manufactured by AbbVie, Inc.Levothyroxine sodium tablets are medically indicated as a replacement therapy for primary...