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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
The European Medicines Agency is launching a 12-month pilot program to improve the usefulness of postmarket safety data by providing drugmakers with targeted advice on postmarket study design. Read More
The FDA zapped three more compounders over sterility issues, with two Tennessee firms receiving Form 483s and a California facility getting hit with a warning letter. Read More
Pfizer has terminated its over-the-counter Lipitor program in the U.S. after a Phase 3 clinical trial showed that patients required a physician’s help to take the cholesterol-lowering drug correctly. Read More
The International Conference on Harmonisation is recommending that drugmakers limit their use of the solvent methylisobutylketone in drug products after two studies showed toxicity in rats and mice. Read More