Breckenridge Pharmaceutical Inc, the US subsidiary of Spain-based Towa International, announced on Monday the launch of Pomalidomide Capsules, a generic version of Pomalyst by Celgene (now Bristol Myers Squibb), within the oncology therapeutic category.
The product was developed in partnership with NATCO Pharma Limited of India.
Pomalidomide Capsules, a thalidomide analogue, are indicated for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. It is also approved for AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy, as well as for HIV-negative adult patients with Kaposi sarcoma.
The product is available in 1mg, 2mg, 3mg, and 4mg strengths and is distributed primarily through specialty pharmacies and clinics.
Pomalidomide Capsules are available only through a restricted programme called PS-Pomalidomide REMS.
Lupin's Dapagliflozin Tablets receive US regulatory approval
Insmed reports Phase 2b study of brensocatib did not meet efficacy endpoints
Dexcel Pharma's Nintedanib Capsules approved for US launch
Gilead to acquire Tubulis to expand ADC oncology capabilities
FDA grants Fast Track status to SIM0505 for platinum‑resistant ovarian cancer
Alloy Therapeutics and Biogen expand partnership with multi-target antisense collaboration
Sanofi reports positive phase 2 results for lunsekimig in asthma and CRSwNP
AstraZeneca reports positive Phase III data for Imfinzi and Imjudo in liver cancer