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Indian drugmaker Hetero has launched a biosimilar version of Roche’s Rituxan on the subcontinent, with plans to introduce it in key markets outside India through strategic partners. 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
The Indian government has canceled talks later this month with the EU’s chief trade negotiator to protest the European Commission’s ban of scores of generic drugs tested by Hyderabad-based GVK Biosciences. Read More
Upsher-Smith Laboratories has launched its generic version of Actavis’ Alzheimer’s drug Namenda immediate release in the U.S. market, following FDA approval of an ANDA, the company said Aug. 10. Read More
The Federal Circuit appeals court has denied AstraZeneca’s effort to block Mylan’s launch of a generic version of the acid reflux blockbuster Nexium, paving the way for additional competition for the drug. Read More
Manufacturers of highly soluble immediate-release tablets and capsules may use standard release tests instead of method development and specification-setting exercises to show how quickly the drug dissolves, the FDA says in draft guidance released July 31. Read More
The Department of Justice is looking into Allergan’s pricing of certain generic drugs as part of a larger federal probe into rising generic prices Read More
A House Energy and Commerce Committee report on cybersecurity breaches at HHS blames the FDA for not acting forcefully enough to prevent a known web vulnerability that has been a security concern for the past decade. Read More
AbbVie is launching new attacks on the FDA’s approach to biosimilar labeling, arguing in a letter posted to regulations.gov that the labels have “indefensible” omissions of how biosimilars and brandname biologics differ. Read More
Drugmakers should limit the amount of acetaminophen in pediatric liquid drugs to 160mg/5mL and include a statement highlighting the concentration on the container and labeling to reduce the chance of overdose, the FDA says. Read More
Drugmakers will have to provide more benefit-risk information in common technical documents submitted to the FDA, European Medicines Agency and other regulators, under revised guidance from the International Conference on Harmonisation. Read More