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Nestle Skin Health and Galderma Laboratories have filed a patent lawsuit against Perrigo and Perrigo UK over patents related to the topical gel Mirvaso, which clears up facial redness. Read More
Earlier this summer the FDA recommended a five-point scale to measure topical patch adhesion for drugmakers submitting ANDAs. However, the recommendations have only raised more questions. Read More
Industry continues to be divided on whether to include interchangeability statements on biosimilar labels, with Amgen taking the lead in support and Merck taking the lead against in comments on the FDA’s March draft biosimilar labeling guidance. Read More
Applications for generics of Johnson & Johnson’s Risperdal should contain characterization data on the reference product and the copycat version, the FDA says. Read More
The U.S. Judicial Panel on Multidistrict Litigation is consolidating price-fixing suits against generics maker Covis Pharmaceuticals for its heart drug Lanoxin. Read More
In a move that may hinder companies looking to develop generic Tyvaso, the combination product’s developer is asking the FDA to impose stringent approval requirements on generic competitors. Read More
Drugmakers seeking approval of fidaxomicin generics to treat Clostridium difficile-associated diarrhea have two options for demonstrating bioequivalence, the FDA said. Read More
To shed light on the regulatory requirements for the development of co-crystals, the FDA is offering drugmakers submitting ANDAs and NDAs a clearer definition of co-crystals that no longer denotes them as an in-process material. Read More
In response to criticism surrounding the price of its EpiPen, Mylan plans to sell a generic version of its allergy treatment for half the price. Read More
Drugmakers submitting ANDAs for new drug strengths face FDA refusals due to insufficient justifications for impurities in the products, the agency says. Read More