Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Venetoclax Tablets, 10 mg, 50 mg and 100 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Venclexta Tablets, 10 mg, 50 mg, and 100 mg, of AbbVie Inc. (AbbVie).
Venetoclax tablets are indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Venetoclax tablets are also indicated, in combination with azacitidine, or decitabine, or low-dose cytarabine, for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
Alembic was a first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Venetoclax Tablets, 10 mg, 50 mg and 100 mg. Therefore, with this approval, Alembic may be eligible for 180 days of generic drug exclusivity.
According to IQVIA, Venetoclax tablets, 10 mg, 50 mg and 100 mg, had an estimated market size of US $1,584 million in the United States for twelve months ending June 2026.
"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."
"Contents which are exclusively for Non-Broking Products/Services, "Mutual Fund, Mutual Fund-SIP, Research reports, Insurance, etc. where the Member is just a distributor. These are not Exchange traded product and the Member is just acting as distributor. It should also state that all disputes with respect to the distribution activity, would not have access to Exchange investor redressal forum or Arbitration mechanism."