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    • Lupin gets USFDA nod...

    Lupin gets USFDA nod for generic equivalent of UNITHROID to treat thyroid

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-09-21T11:22:57+05:30  |  Updated On 21 Sept 2019 11:22 AM IST
    Lupin gets USFDA nod for generic equivalent of UNITHROID to treat thyroid

    Lupin Ltd’s Levothyroxine Sodium Tablets USP, 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 are now AB rated (therapeutically equivalent) with Reference Listed Drugs, SYNTHROID and UNITHROID.


    Mumbai: Pharma major Lupin Limited (Lupin) announced that it has received approval for its ANDA for Levothyroxine Sodium Tablets USP, 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, from the United States Food and Drug Administration (U.S. FDA).


    The approved product is a generic equivalent of UNITHROID 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, manufactured by Jerome Stevens Pharmaceuticals Inc.


    Lupin Ltd’s Levothyroxine Sodium Tablets USP, 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 was originally approved on January 18, 2019 as generic equivalent of SYNTHROID 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, manufactured by ABBVIE Inc.


    With this sANDA approval, Lupin Ltd’s Levothyroxine Sodium Tablets USP, 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 are now AB rated (therapeutically equivalent) with Reference Listed Drugs, SYNTHROID and UNITHROID.


    Lupin’s Levothyroxine Sodium Tablets are indicated for:




    • Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism

    • Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer


    Levothyroxine Sodium Tablets USP (RLD: UNITHROID and SYNTHROID) had annual sales of approximately USD 2581 million in the US (IQVIA MAT June 2019).


    Based in Mumbai, Lupin is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds a Global leadership position in the Anti-TB segment.


    Also Read: Lupin gets USFDA warning letter for Mandideep Unit-1 facility

    AB rated drugsAbbVieFood and Drug Administrationgeneric thyroid drughypothyroidismJerome Stevens PharmaLevothyroxineLevothyroxine Sodium tabletsLupinpharmapharma newspharma news indiaPituitary ThyrotropinReference Listed DrugsRLDSynthroidtherapeutically equivalentthyroidunithroidUSUSFDA

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      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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