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News|Articles|November 2, 2026

FDA Approves Generic Venetoclax Tablets for CLL/SLL and AML

Author(s)Jonah Feldman
Fact checked by: Sabrina Serani

Key Takeaways

  • The FDA granted final approval to Alembic’s generic venetoclax tablets (10-mg, 50-mg, 100-mg), rated therapeutically equivalent to AbbVie’s Venclexta, with the same CLL/SLL and AML indications.
  • Alembic was a first applicant with a paragraph IV certification and may be eligible for 180 days of generic drug exclusivity, following the end of orphan drug exclusivity on May 15, 2026.
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The FDA granted final approval to Alembic's generic venetoclax tablets, rated therapeutically equivalent to Venclexta, for CLL/SLL and newly diagnosed AML.

The FDA has granted final approval to Alembic Pharmaceuticals Limited's abbreviated new drug application (ANDA) for generic venetoclax tablets in 10-mg, 50-mg, and 100-mg strengths.1 The product is rated therapeutically equivalent to the reference listed drug, venetoclax (Venclexta) tablets from AbbVie Inc.

Venetoclax, a BCL2 inhibitor, was first approved in the US in 2016.2 The generic tablets carry the same indications as the reference product: treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and, in combination with azacitidine, decitabine, or low-dose cytarabine, treatment of newly diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older or in those with comorbidities that preclude intensive induction chemotherapy.1,2

Exclusivity and Patent Context

The orphan drug designation for venetoclax’s marketing exclusivity beginning on May 15, 2019, ended on May 15, 2026.3 Alembic reported that it was a first applicant to submit a substantially complete ANDA containing a paragraph IV certification for venetoclax tablets. As a result, the company may be eligible for 180 days of generic drug exclusivity with this approval.1 The approval brings the company's cumulative total to 248 ANDA approvals from the FDA, comprising 228 final approvals and 20 tentative approvals.1

Another generic in the same dose strengths was approved on May 15, 2026, from Dr. Reddy’s Laboratories.4

Safety Profile

According to the reference product's prescribing information, warnings and precautions for venetoclax include tumor lysis syndrome (TLS), neutropenia, infections, and immunization.2 The label directs clinicians to assess TLS risk in all patients and to provide prophylactic hydration and antihyperuricemics before the first dose, and patients with CLL/SLL begin treatment on a 5-week dose ramp-up schedule intended to gradually reduce tumor burden.2 Concomitant use of strong CYP3A inhibitors at initiation and during the ramp-up phase is contraindicated in patients with CLL/SLL, and the dose should be reduced by 50% in patients with severe hepatic impairment.2

REFERENCES
1. Alembic Pharmaceuticals Limited receives USFDA final approval for venetoclax tablets, 10 mg, 50 mg and 100 mg. News release. Alembic Pharmaceuticals Limited. October 30, 2026. Accessed November 2, 2026. https://tinyurl.com/274njrzc
2. Venclexta. Prescribing information. AbbVie Inc; 2026. Accessed November 2, 2026. https://tinyurl.com/yc3fv9fr
3. Search orphan drug designations and approvals: venetoclax. US Food and Drug Administration. Accessed November 2, 2026. https://tinyurl.com/596kwpwv
4. First-time generic approvals 2026. Drugs.com. Accessed November 2, 2026. https://tinyurl.com/2dnjdjxz

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