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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manufacturing and controls in ANDAs and other drug and biologics submissions must be reported to the FDA, saying draft guidance lacks clear criteria and examples.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
Indian generics maker Lupin is set to buy privately held U.S. generics maker Gavis Pharmaceuticals for $880 million, a move that expands Lupin’s share of the U.S. generics market. Read More
United Therapeutics has filed suit in federal court in New Jersey, claiming Allergan’s Paragraph IV ANDA for a generic version of its hypertension drug Tyvaso violates three of the drug’s patents. Read More
A U.S. district court in Maryland has let stand the FDA’s November 2014 decision to revoke Mallinckrodt’s equivalence rating for its generic version of Janssen’s ADHD drug Concerta. Read More
Hikma Pharmaceuticals is purchasing Boehringer Ingelheim’s Roxane generics unit for $2.65 billion, in a deal that will make the Jordanian drugmaker the sixth largest provider of generics by revenue in the U.S. Read More
Teva is paying $40.5 billion to acquire drugmaker Allergan’s generic division, walking away from efforts to purchase Mylan for a similar amount. Read More
The European Commission is suspending sales and distribution of 700 formulations of more than four dozen generic drugs after determining that the bioequivalence testing on which their approvals were based included manipulated echocardiogram data. Read More
The FDA continues to crack down on generic drugmakers that owe GDUFA fees, hitting Indian drugmaker Vista Pharmaceuticals with a warning letter for failing to pay fees for the last three fiscal years. Read More
The list of states allowing substitution of biosimilars for prescription medicines nearly doubled in the first half of 2015, as seven states joined the list of eight that passed similar laws in 2013 and 2014. Read More