We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The list of states allowing substitution of biosimilars for prescription medicines nearly doubled in the first half of 2015 as seven states joined the list of eight that passed similar laws in 2013 and 2014. Read More
United Therapeutics has filed suit in federal court in New Jersey, claiming Allergan’s Paragraph IV ANDA for a generic version of its hypertension drug Tyvaso violates three of the drug’s patents. Read More
A U.S. district court in Maryland has let stand the FDA’s November 2014 decision to revoke Mallinckrodt’s equivalence rating for its generic version of Janssen’s ADHD drug Concerta. Read More
Pfizer’s Dalian, Liaoning, China, facility received a six-observation Form 483 from the FDA for retesting failed samples, poor record controls and using an open pit for a urinal. Read More
GlaxoSmithKline, which last year paid Chinese authorities $483 million to settle corruption charges, is facing similar allegations in Romania. Read More