This article was originally published in Pharmaceutical Approvals Monthly
Forest may be able to delay generic competition against Tiazac because of a recently listed patent on the diltiazem product. Biovail, which licenses the agent to Forest, listed patent 6,162,463 in the FDA "Orange Book," the firm announced Jan. 30. ANDA applicants will be required to certify to the new patent and FDA cannot approve any applications for 30 months, unless a court ruling comes sooner. Andrx was getting ready to launch a generic version of Tiazac in February under the trade name Taztia XT
You may also be interested in...
When asked about an inspector general report that found hospitals are struggling with tests and resources, and are looking to the federal government to help facilitate more efficient distribution of medical devices to fight the COVID-19 crisis, President Trump attacked the report as a political hit from an Obama holdover.
Japanese medical device manufacturer Terumo Corp. promoted senior management execs; MiMedx Group, developer of human placental tissue allografts, raised exec to CFO; and more.
COVID-19: String Of FDA Guidance Docs Lay Bare Enforcement Policies For Infusion Pumps, ECMO Devices, Thermometers, And More
In three separate immediately-in-effect guidance documents, the US agency says makers of infusion pumps and accessories, extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices, and remote ophthalmic assessment and monitoring devices can make “limited modifications” to those products so they can be used during the ongoing novel coronavirus crisis, without the need for firms to seek out a new 510(k). A fourth guidance says clinical electronic thermometers that aren’t yet 510(k)-cleared by the FDA can be distributed for use.