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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
Pfizer has acquired exclusive rights to market potential generic versions of Teva’s multiple sclerosis drug Copaxone, under an agreement with Synthon. 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
Genzyme received a 16-observation Form 483 from the FDA for not conducting risk assessments and other quality lapses at a facility where bulk drug substances are made. 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
The Senate and House Appropriations Committees are calling on the FDA to issue guidance on biosimilars standards and work with industry to prevent drug shortages as part of their fiscal 2016 funding bills. Read More
Drugmakers want to know when changes to chemical, manufacturing and controls in ANDAs and other drug and biologics submissions must be reported to the FDA, saying draft guidance lacks clear criteria and examples. Read More
Beleaguered Indian generics maker Wockhardt is conducting its third U.S. recall since the end of April — this time pulling 162,142 cartons of drugs used to treat high blood pressure and ulcers. Read More