Lupin Receives Tentative Approval from U.S. FDA for Pitolisant Tablets

Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Pitolisant Tablets, 4.45mg and 17.8mg. This product would be manufactured at Lupin's Nagpur facility in India.

The U.S. FDA has tentatively approved Lupin's Pitolisant Tablets 4.45mg and 17.8 mg as bioequivalent to Wakix® for the indication in the approved labeling.

Shares of Lupin Limited was last trading in BSE at Rs. 2347.45 as compared to the previous close of Rs. 2331.75. The total number of shares traded during the day was 18180 in over 2396 trades.

The stock hit an intraday high of Rs. 2360.00 and intraday low of 2331.75. The net turnover during the day was Rs. 42686358.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Pharmaceuticals USFDA TentativeApproval ANDA PitolisantTablets