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The FDA has laid out new goals for speeding up its handling of regulatory submissions from generics makers that eventually call for 90 percent of some prior approval supplements to be acted on within six months and ANDA amendments to be acted on within 10 months. Read More
Avanir Pharmaceuticals has settled with generic firm Ranbaxy over its bid to produce a version of the brand manufacturer’s Nuedexta, the first drug approved in the U.S. to treat pseudobulbar affect (PBA). Read More
Massachusetts has become the eighth state to pass a law enabling pharmacists to substitute a biosimilar for a branded biological product, earning praise from industry groups that believe such state laws are vital to biosimilar adoption. Read More
The U.S. Patent and Trademark Office’s recently established patent review board has received what appears to be its first challenge to a drug patent covering a business practice rather than a drug’s attributes. Read More
The FDA would require biosimilars to carry the same name as their reference drug counterparts under a proposal being pushed by healthcare payers and GPhA. Read More
Generic drugmaker Mylan agreed to pay Abbott Labs $5.3 billion in stock to acquire part of its international generic drug business in a deal that vastly spreads the geographic reach of the Pennsylvania-based firm. Read More
Pfizer is facing at least three class action lawsuits alleging that the company went to extraordinary, fraudulent lengths to maintain exclusivity over its multibillion dollar arthritis pain drug Celebrex and keep generic competitors off the market. Read More
GPhA is stepping up its opposition to the FDA’s proposed generics labeling rule, releasing a survey that shows more than half of physicians, physician assistants and pharmacists would find the new system confusing for them and their patients. Read More
Top Republican lawmakers want the Obama administration to examine whether the FDA has the authority to impose a generic drug labeling rule, ratcheting up the rhetoric in an increasingly political battle over the controversial measure. Read More
Generic drugmaker Mylan agreed to pay Abbott Labs $5.3 billion in stock to acquire part of its international generic drug business in a deal that vastly spreads the geographic reach of the Pennsylvania-based firm. Read More