Enforcement Report - Week of June 7, 2023
New Jersey-based generic drugmaker Heritage Pharmaceuticals admitted to fixing prices and will pay more than $7 million in criminal and civil damages, the Department of Justice (DOJ) announced Friday.
The $3 pill known as BiDil was already a difficult sell when a Georgia-based pharmaceutical company bought the marketing rights a few years ago. A treatment for African Americans suffering from heart failure, BiDil had never really caught on, forcing the drug company that developed it to take a buyout offer. One strike against the drug was a 2009 study that raised questions about its safety and effectiveness.
A new analysis unveiled by the industry’s two biggest lobbies–the American Hospital Association and the Federation of American Hospitals–is the latest salvo in an escalating battle in Washington over prescription drug costs. Lately, drug makers like Mylan MYL -3.38% deflect price hikes for the EpiPen on pharmacy benefit managers while PBMs and insurers point fingers at the pharmaceutical industry. Hospitals are now entering the fray, with a University of Chicago analysis showing large price increases in just a short time on medicines that have generally been around for years, such as drugs used during surgery or anesthesia.
Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Hydralazine Hydrochloride Injection USP, 20 mg/mL, which is a generic version of Novartis' Apresoline Injection, 20 mg/mL. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is used for the treatment of severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.
X-Gen`s Generic Hydralazine Hcl (20Mg/Ml) Approved in US For Hypertension
Par Pharmaceutical Inc., Ongoing Class II recall of HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977 because of Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.