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A federal court decision this fall granting orphan drug marketing exclusivity to Depomed’s post-shingles pain drug Gralise will stand, after the FDA withdrew an appeal filed earlier this week. Read More
The entire class of prescription and over-the-counter proton pump inhibitors do not require a boxed warning, but some prescription PPIs should contain a medication guide, the FDA said in response to a long-waiting citizen petition. Read More
The FDA is asking drugmakers to use the data universal numbering system (DUNS) to register their manufacturing facilities in the U.S. and abroad. Read More
The Republican landslide in Tuesday’s midterm election will put GOP lawmakers in the driver’s seat on the generics labeling rule, user-fee negotiations and agency funding, but experts say the political shift’s impact remains uncertain. Read More
Generic drugmakers want the FDA to better define what qualifies for a “controlled correspondence” under a draft guidance that aims to speed agency responses to manufacturer queries. Read More
To avert drug shortages, Health Canada has partially lifted an import ban on products from three Indian manufacturing facilities that were barred from doing business in the country due to quality violations. Read More
Cipla has asked the Indian government to forcibly revoke five patents covering Novartis’s lung disease drug Onbrez to pave the way for generic versions in the country, a move the Indian manufacturer says is needed to address a significant unmet need for the therapy. Read More
An Indian pharma group contends the U.S. Trade Representative’s scrutiny of India’s intellectual property regime could dampen investment in the country. Read More
To make it easier for generics firms to create versions of complex drugs, the FDA is asking industry to identify drug products it would like to see bioequivalence testing guidances written for. Read More
Generic drugmakers frequently miscalculate the amount of user fees they owe the FDA, a situation that has landed many companies on the GDUFA arrears list, the head of the FDA’s user fee management division said. Read More
Manufacturers of forthcoming biosimilars argue that their products should have the same international non-propriety name (INN) as the reference product, and do not need a unique qualifier to distinguish them from the brand version for the purposes of tracking. Read More
Two lawmakers want HHS Secretary Sylvia Burwell to address questions about efforts by the Obama administration to bring rising generic prices under control. Read More