Simplifying Global Compliance
Due to the holidays, Generic Line
will not be published Dec. 18. The next issue will be published Jan. 1, 2014. Read More
The FDA’s proposed new labeling requirements for generics pose such a challenge to industry that GPhA has asked the FDA for an additional two months to comment on the proposed rule. Read More
The FDA Nov. 27 hit Wockhardt with a second “import alert,” banning drug products from its Chikalthana plant in western India — the latest in a spate of regulatory actions taken against the struggling drugmaker. Read More
Chinese authorities are gearing up to keep the cost of certain drugs sold in the country down via publication of a “low-cost” drug list expected to expand access to generics. Read More
Eli Lilly and Acrux on Nov. 12 filed suit against Actavis to prevent the generic drugmaker from commercializing a generic version of the testosterone topical solution Axiron. Read More
The Generic Drug User Fee Amendments of 2012 do not allow for a waiver, reduction or postponement of finished dosage form (FDF) facility fees for small and/or foreign businesses, the FDA says in a letter denying a citizen petition submitted by Square Pharmaceuticals. Read More
Drugmakers have 14 additional calendar days to comment on recently revised GDUFA question-and-answer guidance after technical difficulties prevented stakeholders from submitting comments on Regulations.gov. Read More
The FDA is investigating reports that emergency contraceptives such as Teva’s Plan B One-Step lose effectiveness in women over 165 lbs. and don’t work at all for women over 175 lbs. Based on its review, labeling changes for the drugs may be forthcoming.< Read More
Teva and Mylan said Nov. 25 they had reached a confidential agreement to settle patent litigation over Teva’s multiple sclerosis drug Copaxone in three European courts. Read More
The White House Office of Management and Budget’s decision to sequester nearly $85 million of FDA user fees is wrong, and should be reversed immediately, lawmakers say. Read More
Twenty-five drugmakers, including generic drugmakers Ranbaxy and Perrigo, have agreed to pay the state of Louisiana more than $88 million to settle Medicaid and Medicare fraud charges lodged against them as part of the state’s continuing crusade to recover funds paid out to drug companies improperly. Read More
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