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Ritalin manufacturer Celgene, and its distributor, Novartis, could experience major losses in revenue if they lose patent litigation in federal court to block a generic version of their attention-deficit/hyperactivity disorder (ADHD) treatment, according to Celgene.
A federal court has blocked plans by Mylan Laboratories to launch amlodipine besylate, a generic version of Pfizer’s blockbuster drug Norvasc, during the drug’s pediatric exclusivity period.
The U.S. Court of Appeals for the District of Columbia heard arguments last week in a landmark case to decide if terminally ill patients have a constitutional right to use drugs that have not been fully approved by the FDA.
The U.S. Patent and Trademark Office rejected claims in a key patent covering Genentech’s respiratory treatment drug, Synagis, the company said, noting that it is contemplating challenging the decision.
Former FDA Commissioner Lester Crawford will have to pay $90,000 in penalties and serve three years of probation for federal fraud charges levied against him for failing to disclose financial conflicts of interest and making false statements, his attorney said.
A federal court has blocked plans by Mylan Laboratories to launch amlodipine besylate, a generic version of Pfizer’s blockbuster drug Norvasc, during the drug’s pediatric exclusivity period.
Ritalin manufacturer Celgene, and its distributor, Novartis, could experience major losses in revenue if they lose patent litigation in federal court to block a generic version of their attention-deficit/hyperactivity disorder (ADHD) treatment, according to Celgene.
Former FDA Commissioner Lester Crawford will have to pay $90,000 in penalties and serve three years of probation for federal fraud charges levied against him for failing to disclose financial conflicts of interest and making false statements, his attorney said.
Astellas Pharma is moving to extend patent protection for its enlarged-prostate treatment Flomax, a blockbuster drug that generated more than $1 billion in sales last year, the company said.