Cabazitaxel Approval announced
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®). This product was developed in collaboration with Natco Pharma Limited.
Tentative Approval For Generic Pradaxa (Dabigatran)
Breckenridge Announces Tentative Approval of its ANDA for Dabigatran Etexilate Capsules (generic for Pradaxa®)
New-Product Agreement with PTS Pharma Signed
Breckenridge Signs New-Product Agreement with PTS Pharma
Miglustat (Zavesca) Approved
Breckenridge Announces Approval of its ANDA for Miglustat Capsules (generic for Zavesca®)
Penicillamine Capsule Launch
Breckenridge Pharmaceutical, Inc. Announces Launch of Penicillamine Capsules, USP (generic for Cuprimine®)
Lacosamide (Vimpat) Launch
Breckenridge Pharmaceutical, Inc. Announces Launch of Lacosamide Tablets, USP (generic version of Vimpat®) Manufactured by MSN Laboratories Private Limited
Everolimus 10mg (Afinitor) Launched
Breckenridge Pharmaceutical, Inc. announces today that it has launched the 10mg strength of Everolimus Tablets (generic for Afinitor®). The U.S. Food and Drug Administration previously granted final approval of this Abbreviated New Drug Application.
ANDA Approval for Teriflunomide Tablets
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®). This product was developed in collaboration with PharmaZell GmbH, Germany.
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.
