Breckenridge Announces Final Approval of its ANDA for Everolimus Tablets (generic for Afinitor®)
Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Everolimus Tablets (generic for Afinitor®). This product was developed in collaboration with Natco Pharma Limited. According to industry sales data, Afinitor and its therapeutic equivalents generated annual sales of $712 million during the twelve months ending December 2020. Breckenridge plans to launch Everolimus Tablets in 2.5mg, 5mg and 7.5mg strengths during the second quarter of 2021 in a blister card packaging configuration. Breckenridge’s launch of the product’s 10mg strength is based on terms that are presently confidential and will be announced at a later date.
Breckenridge Announces Final Approval of its ANDA for Asenapine Sublingual Tablets, 2.5 and 10mg Strengths (generic for Saphris®)
Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Asenapine Sublingual Tablets in 2.5mg and 10mg strengths (generic for Saphris®). Breckenridge plans to launch these strengths immediately. Additionally, the U.S. Food and Drug Administration granted tentative approval for the 5mg strength. This product was developed in collaboration with MSN Laboratories Private Limited. According to industry sales data, Saphris® generated annual sales of $239 million during the twelve months ending September 2020.
Breckenridge Announces Final Approval of its ANDA for Pomalidomide Capsules (generic for Pomalyst®)
Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has approved Breckenridge’s Abbreviated New Drug Application for Pomalidomide Capsules (generic for Pomalyst®).
Towa completes acquisition of Esteve’s Generic Division
Berlin, CT January 31, 2020 – Breckenridge Pharmaceutical, Inc. announced today that Towa Pharmaceutical Co., Ltd. has completed its acquisition of Esteve’s generics division, including Breckenridge.
