Breckenridge announces final FDA approval for Everolimus tablets for oral suspension, AB-rated to AFINITORDISPERZ ®

Berkeley Heights, New Jersey, January 29, 2025 Breckenridge Pharmaceutical, Inc.,-the U.S. subsidiary of Towa International that markets, distributes, and sells generic pharmaceuticals in the United States, – announced today that the Food and Drug Administration (FDA) has granted final approval of Everolimus Tablets for Oral Suspension (TFOS), 2mg, 3mg and 5mg, a generic version of […]
Breckenridge announces final FDA approval for Methadone Hydrochloride Multi-Dose Injection

Berkeley Heights, New Jersey, December 18, 2024 Breckenridge Pharmaceutical, Inc., the U.S. subsidiary of Towa International that markets, distributes, and sells generic pharmaceuticals in the United States, announced today that the U.S. Food and Drug Administration has granted final approval of its Methadone Hydrochloride Injection USP, 200 mg/20 mL (10 mg/mL) Multi-Dose Vial which it […]
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.