Alembic Pharmaceuticals Secures USFDA Approval for Generic Levothyroxine Sodium Tablets
Alembic gets USFDA nod for generic levothyroxine sodium tablets

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Alembic Pharmaceuticals Ltd has received final approval from the US Food & Drug Administration (USFDA) for its generic levothyroxine sodium tablets, which are used as a replacement therapy for hypothyroidism. The approved product includes multiple strengths and is therapeutically equivalent to AbbVie’s Synthroid tablets, with a projected market size of approximately $1.87 billion by March 2026.
- 01The approved generic levothyroxine sodium tablets come in strengths ranging from 25 mcg to 300 mcg.
- 02Levothyroxine sodium is used to treat primary, secondary, and tertiary hypothyroidism, and is also an adjunct in thyroid cancer treatment.
- 03The reference drug for the approved ANDA is Synthroid, manufactured by AbbVie, Inc.
- 04The estimated market size for levothyroxine sodium tablets is projected to reach $1.87 billion by March 2026, according to IQVIA data.
- 05Alembic's approval marks a significant step in expanding its portfolio in the US market.
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Alembic Pharmaceuticals Ltd, based in New Delhi, has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its generic version of levothyroxine sodium tablets. This medication is primarily indicated for use as a replacement therapy for patients suffering from hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormone. The approval pertains to the Abbreviated New Drug Application (ANDA) for levothyroxine sodium tablets in various strengths, 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. These tablets are therapeutically equivalent to AbbVie’s Synthroid tablets, which serve the same purpose. Levothyroxine sodium is not only used to treat congenital or acquired hypothyroidism but also acts as an adjunct to surgery and radioiodine therapy in managing thyrotropin-dependent well-differentiated thyroid cancer. According to IQVIA data, the market for levothyroxine sodium tablets is estimated to be worth approximately $1.87 billion by March 2026, highlighting the significant demand for this medication.
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The approval of Alembic's generic levothyroxine sodium tablets could lead to more affordable treatment options for patients with hypothyroidism in the US market.
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