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Beleaguered Indian generics maker Wockhardt is recalling 93,393 bottles of its blood pressure medicine Captopril in the U.S., after discovering the tablets failed to meet specification for thickness. Read More
India’s Supreme Court has temporarily barred Glenmark Pharmaceuticals from making new copies of Merck’s diabetes drugs Januvia and Janumet, but the Mumbai-based company may continue to sell its existing stock. Read More
Washington State Gov. Jay Inslee has signed legislation allowing pharmacists to substitute biosimilars for brandname biologics, joining a growing list of states that have passed such laws. Read More
Endo International has agreed to buy Par Pharmaceutical from private equity firm TPG for $8 billion, in a deal the companies say will put them within the top five firms in the U.S. generics market. Read More
The former chairman of the Senate Veterans Affairs Committee is pressing the VA to invoke a wartime provision to break the patents on Gilead Sciences’ pricey hepatitis C drug Sovaldi, after the agency stopped treating veterans because it had exceeded the more than $400 million budgeted for hep C treatment. Read More
AbbVie has been sued over an alleged pay-for-delay scheme involving its blockbuster testosterone drug AndroGel, two days after a federal court in Pennsylvania dismissed some claims in a similar suit filed last year by the Federal Trade Commission. Read More
Ranbaxy is being accused in federal court of filing ANDAs with false documentation in an effort to block generic competitors from coming to market. Read More
The FDA wants to know how patient perceptions of medications change when pharmacies switch from brand to generic drugs or from one generic to another, as in the case of a new supplier. Read More
Actavis plans to immediately relaunch its generic version of AstraZeneca’s inhaled asthma drug Pulmicort Respules, following a federal appeals court decision upholding a lower court ruling that invalidated the brandmaker’s patent on the drug. Read More
The FDA wants biosimilars makers to retain for at least five years reserve samples of products used in comparative pharmacodynamic and pharmacokinetic studies intended to support an ANDA. Read More
Generics makers are asking the European Commission to clarify new requirements for factory acceptance and site acceptance testing, including the number of batches that need to be validated when bracketing is applied. Read More