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In July, the FDA issued a decision letter relating to Suboxone generics, ruling that ANDA applicants can qualify for 180-day exclusivity whether or not they provide a certification under Paragraph IV. Read More
The judge said the plaintiffs “have not sufficiently alleged that Teligent had an opportunity to conspire with the other econazole defendants.” Read More
The U.S. Court of Appeals for the Federal Circuit upheld a 2017 ruling by the Patent Trials and Appeals Board rejecting Forward Pharma’s challenge to Biogen’s Tecfidera patent. Read More
The agency pointed out in its denial letter that the 180-day exclusivity period did not begin until Aug. 29, when the company actually notified the agency that it had begun commercial marketing. Read More
“Research suggests that using these formats to express probabilities when communicating health information can improve consumers’ comprehension and ability to recall the information” and improve their processing and evaluation, the agency said. Read More
The committee agreed that the company’s trial data showed the drug to be effective and that it adequately addressed the potential risk of cardiovascular adverse events. Read More
The FDA cited an API manufacturing facility in Torrance, California, for deficiencies in quality assurance, preventive maintenance, audits and batch records. Read More