April 25, 2012 | Vol. 29 No. 9 | Full Issue in PDF Format
The Supreme Court has unanimously ruled that generic-drug maker Caraco Pharmaceuticals can challenge Novo Nordisk’s “overbroad” patent listing for diabetes drug Prandin, reversing and remanding a lower court’s decision that critics called an existential threat to the generic industry.
GPhA has tapped IMS Health to lead its much-anticipated Accelerated Recovery Initiative (ARI), a data-sharing program linking the FDA and regulated industry designed to speed the recovery of critical need drugs in short supply.
Hospira is recalling one lot of its morphine sulfate injection after finding manufacturing irregularities.
Drugmakers commenting on the FDA’s trio of biosimilars guidance documents are split on the need for certain clinical tests as part of the agency’s stepwise approach to showing biosimilarity.
Democrats in the House and Senate have introduced companion bills that would allow generic-drug makers to update safety warnings on labeling without waiting for the brand drugmaker to do it first.
The European Medicines Agency (EMA) has published question-and-answer guidance on marketing applications for biosimilars, providing advice on a number of pre-submission issues, such as requesting an accelerated assessment, and giving detailed answers about review timing.
The FDA could require drugmakers seeking NDA approval on new formulations or doses on previously approved molecules to resolve outstanding patent litigation before a new approval is granted to prevent “evergreening,” or delaying of generic competition.
ViroPharma is suing the FDA and is seeking a temporary restraining order for three newly approved generics of its gastrointestinal antibiotic Vancocin.
AstraZeneca (AZ) is launching Dutoprol, a spinoff of its blood-pressure drug Toprol-XL, to compete with generic versions of the older product.
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