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Mumbai: Global pharma major Lupin Limited (Lupin) today announced that it has received the final approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Pitolisant Tablets, 4.45 mg and 17.8 mg.
The U.S. FDA has approved Lupin’s Pitolisant Tablets, 4.45 mg and 17.8 mg, as bioequivalent to Wakix® for the indications in the approved labeling.
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𝗕𝗘𝗠𝗟 𝗦𝗲𝗰𝘂𝗿𝗲𝘀 ₹𝟭𝟴𝟰 𝗖𝗿𝗼𝗿𝗲 𝗢𝗿𝗱𝗲𝗿 𝗳𝗿𝗼𝗺 𝗛𝗔𝗟 𝗳𝗼𝗿 𝗕𝘂𝗶𝗹𝗱𝗶𝗻𝗴 𝗟𝗖𝗛 𝗙𝘂𝘀𝗲𝗹𝗮𝗴𝗲
