Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol-Myers Squibb Company (BMS). Dasatinib tablets are indicated for the treatment of adult patients with: (i) newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, (ii) chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib, (iii) Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are also indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. Refer label for a detailed indication.
Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, have an estimated market size of US$ 1,017 million for twelve months ending September 2025 according to IQVIA.
"Prevent unauthorised transactions in your account ; Update your mobile numbers/email IDs with Us. Receive information of your transactions directly from Exchange on your mobile/email at the end of the day” - Issued in the interest of Investors"
"KYC is one time exercise while dealing in securities markets - once KYC is done through a SEBI registered intermediary (broker, DP, Mutual Fund etc.), you need not undergo the same process again when you approach another intermediary."
"No need to issue cheques by investors while subscribing to Equity IPO. Just write the bank account number and sign in the application form to authorise your bank to make payment in case of allotment. No worries for refund as the money remains in investor's account."