Breckenridge Pharmaceutical, Inc.

92 articles about Breckenridge Pharmaceutical, Inc.

• Breckenridge Announces Approval of its ANDA for Cabazitaxel Intravenous Solution (generic for Jevtana Kit®)

  8/1/2022

  Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Cabazitaxel Intravenous Powder (generic for Jevtana Kit®).

• Breckenridge Announces Approval of its ANDA for Miglustat Capsules (generic for Zavesca®)

  4/21/2022

  Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Miglustat Capsules (generic for Zavesca®), 100mg strength. 

• Breckenridge Pharmaceutical, Inc. Announces Launch of Penicillamine Capsules, USP (generic for Cuprimine®)

  4/20/2022

  Breckenridge Pharmaceutical, Inc. announced today that it has launched Pencillamine Capsules, USP (generic for Cuprimine®). 

• Breckenridge Pharmaceutical, Inc. Announces Launch of Lacosamide Tablets, USP (generic version of Vimpat®) Manufactured by MSN Laboratories Private Limited

  4/19/2022

  Breckenridge Pharmaceutical, Inc. announces that it has launched Lacosamide Tablets, USP (generic version of Vimpat®).

• Breckenridge Announces Launch of its 10mg strength for Everolimus Tablets (generic for Afinitor®)

  10/1/2021

  Breckenridge Pharmaceutical, Inc. announces today that it has launched the 10mg strength of Everolimus Tablets (generic for Afinitor®).

• Breckenridge Announces Approval of its ANDA for Teriflunomide Tablets (generic for Aubagio®)

  9/29/2021

  Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Teriflunomide Tablets (generic for Aubagio®).

• Breckenridge Pharmaceutical, Inc. Announces Launch of Norepinephrine Bitartrate Injection, USP (generic for Levophed®)

  8/20/2021

  Breckenridge Pharmaceutical, Inc. announces today that it has launched Norepinephrine Bitartrate Injection, USP (generic for Levophed ® ), manufactured by Rafarm S.A. 

• Breckenridge Announces Final Approval of its ANDA for Apixaban Tablets (generic for Eliquis®)

  8/5/2021

  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®).

• Breckenridge Pharmaceutical, Inc. Announces Launch of Zolpidem Tartrate Extended-Release Tablets, USP (generic for Ambien® CR)

  7/8/2021

  Breckenridge Pharmaceutical, Inc. announced that it has launched Zolpidem Tartrate Extended-Release Tablets, USP, manufactured by Centaur Pharmaceuticals Pvt. Ltd.

• Breckenridge Signs Multi-Product Agreement With Welding GmbH & Co, K.G.

  7/2/2021

  Breckenridge Pharmaceutical, Inc. announces 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.

• Breckenridge Signs Multi-Product Agreement With Aggrega Pharma LLC

  6/22/2021

  Breckenridge Pharmaceutical, Inc. announces 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.

• Breckenridge Announces Approval of its ANDA for Carfilzomib Intravenous Powder (generic for Kyprolis®)

  6/16/2021

   Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Carfilzomib Intravenous Powder (generic for Kyprolis®).

• Breckenridge Announces Final Approval of its ANDA for Everolimus Tablets (generic for Afinitor®)

  3/8/2021

  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®).

• Breckenridge Announces Final Approval of its ANDA for Asenapine Sublingual Tablets, 2.5 and 10mg Strengths (generic for Saphris®)

  12/11/2020

  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. Foo

• Breckenridge Announces Final Approval of its ANDA for Pomalidomide Capsules (generic for Pomalyst®)

  11/13/2020

  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®).

• Breckenridge Announces Final Approval of ANDA for Erlotinib Hydrochloride Tablets (generic for Tarceva®)

  11/12/2019

   Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for an Abbreviated New Drug Application for Erlotinib Hydrochloride Tablets, generic for Tarceva®.

• Breckenridge Announces Final Approval of its ANDA for Imatinib Mesylate Tablets (RLD: Gleevec®)

  3/4/2019

   Breckenridge Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Imatinib Mesylate Tablets, generic for Gleevec® Tablets by Novartis.

• Breckenridge Announces Final Approval of its ANDA for Exemestane Tablets (Aromasin®)

  2/27/2019

  Exemestane Tablets generated annual sales of $65 million during the twelve months ending December 31, 2018, according to industry sales data.

• Breckenridge Announces Tetracycline Capsules Launch

  2/12/2019

  The U.S. Food and Drug Administration had granted final approval for this Abbreviated New Drug Application on November 7, 2018.

• Breckenridge Announces Final Approval of its ANDA for Clobazam Tablets (Generic for Onfi®)

  10/23/2018

  Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Clobazam Tablets, CIV, generic for Onfi® Tablets by Lundbeck.