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AbbVie filed a citizen petition Wednesday urging the FDA to establish clear and transparent labeling requirements for biosimilars, saying this will avoid potentially unsafe substitution of the products and their reference products. Read More
The number of critical deficiencies at pharma facilities registered in the UK nearly doubled from 2012 to 2013, spurred mainly by problems with data integrity, regulators say. Read More
A judge dismissed claims that the FDA is precluded from approving generic versions of Otsuka’s blockbuster antipsychotic until its orphan exclusivity expires. Read More
The FDA has warned three more drug compounding pharmacies over sterility issues and other GMP shortcomings, bringing to 12 the number cited since October. Read More
The FDA is still not convinced that Sprout Pharmaceutical’s libido-enhancing drug for women is safe, particularly when mixed with alcohol, and has asked two of its advisory committees to consider whether alcohol should be contraindicated in the product’s labeling. Read More
Novartis has filed a complaint in federal court alleging Apotex infringed on its patent by seeking to manufacture, market and sell a generic version of cancer drug Zometa. Read More