Norepinephrine Bitartrate Injection, USP launch
Breckenridge Pharmaceutical, Inc. Announces Launch of Norepinephrine Bitartrate Injection, USP (generic for Levophed®)
Apixaban Tablets (generic for Eliquis®) Approved
Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Apixaban Tablets (generic for Eliquis®). This product was developed by Towa Pharmaceutical Europe, S.L. in its manufacturing facility located in Martorelles, Spain.
Zolpidem Tartrate Extended-Release Tablets, USP (generic for Ambien® CR) launch
Breckenridge Pharmaceutical, Inc. announced today that it has launched Zolpidem Tartrate Extended-Release Tablets, USP (generic for Ambien® CR), manufactured by Centaur Pharmaceuticals Pvt. Ltd. Breckenridge will market the product in its own label and offer 6.25 mg and 12.5 mg strengths in bottles of 100. According to industry sales data, Ambien CR and its generics had annual sales of $42 million during the twelve months ending May 2021. The U.S. Food and Drug Administration previously granted final approval of this product’s Abbreviated New Drug Application.
Multi-Product Agreement With Welding GmbH & Co, K.G.
Breckenridge Pharmaceutical, Inc. announces today that it has signed a multi-product agreement with Welding GmbH & Co. under which Welding will develop, manufacture and supply pharmaceutical products for marketing, sale and distribution by Breckenridge. The agreement currently covers one delayed release tablet product and two injectable products. Of these three products, one ANDA has been submitted to the U.S. Food and Drug Administration, one ANDA is expected to be submitted to the U.S. Food and Drug Administration in July, and one ANDA is in an advanced stage of development. According to industry sales data, the brand and generics of these three products had annual sales of $300 million during the twelve months ending April 2021.
Breckenridge Signs Multi-Product Agreement With Aggrega Pharma LLC
Breckenridge Pharmaceutical, Inc. announces today that it has signed a multi-product agreement with Aggrega Pharma, LLC. under which Aggrega will develop, manufacture and supply pharmaceutical products for marketing, sale and distribution by Breckenridge.
Carfilzomib Approval Generic Kyprolis
Breckenridge Announces Approval of its ANDA for Carfilzomib Intravenous Powder (generic for Kyprolis®)
Everolimus / Zortress Approval 06-01-2021
Breckenridge Announces Final Approval of its ANDA for Everolimus Tablets (generic for Zortress®)
Breckenridge Announces Final Approval of its ANDA for Asenapine Sublingual Tablets, 5 mg Strength (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 5mg strength (generic for Saphris®). Breckenridge plans to launch this strength immediately. Breckenridge previously launched the product’s 2.5mg and 10mg strengths and will now market all three strengths. This product was developed in collaboration with MSN Laboratories Private Limited. According to industry sales data, Saphris® generated annual sales of $233 million during the twelve months ending December 2020.
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.
