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April 24, 2014

Vol. 31
No. 9


Full Issue of Generic Line in PDF Format

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Chief Justice Roberts Denies Teva’s Appeal for Stay on Copaxone Ruling

U.S. Supreme Court Chief Justice John Roberts on April 18 denied Teva’s attempt to recall and stay a lower court’s ruling that invalidated a patent on Copaxone, opening the gate for generic versions of the blockbuster multiple sclerosis drug to reach the market as early as next month. Read More

Generic Drugmakers Call for U.S., EU To Align on Approvals, Inspections

GPhA and its European counterpart want the FDA and European Medicines Agency to create uniform approval pathways for biosimilars and generics, saying standardization would lower drug costs and eliminate the need for duplicate clinical trials for the same product. Read More

ICH Offers Tips for Complying With Benefit-Risk Reporting Program

Drugmakers should include information for all uses of a product — including off-label uses — when preparing periodic benefit-risk evaluation reports, the International Council on Harmonisation says in new Q&A guidance. Read More

Canada’s Patent Laws Targeted In Lawmakers’ Letter to USTR

U.S. lawmakers are asking the Office of the United States Trade Representative to put Canada back on its priority watch list after the country withdrew a number of patents for drugs sold by American drugmakers. Read More

2015 Deadline for Track-and-Trace Requirements Unrealistic: Pharma

Drugmakers and distributors are asking the FDA to delay strict enforcement of federal track-and-trace requirements, since most companies won’t be able to meet the first deadlines for exchanging transaction data. Read More

European Regulator Joins Review of Testosterone Drugs Safety

The European Medicines Agency is looking into potential heart risks linked to testosterone-containing drugs after an EU member state regulator raised safety concerns. Read More

Canton Is Latest Indian Drugmaker Banned From Importing into U.S.

The FDA has banned imports from active pharmaceutical ingredient maker Canton Laboratories, the fourth Indian drugmaker in a month to be put on import alert for poor quality. Read More

Pfizer, Teva Reach Agreement on Delay of Generic Celebrex

Israeli drugmaker Teva announced April 17 that it has reached a settlement with Pfizer to hold back marketing generic Celebrex (celecoxib) in the U.S. until December. Read More

EU GMP Guidelines Pose New Quality Obligations for Drugmakers

The European Commission is mandating that drugmakers implement a detailed protocol for transferring testing methodology from one lab to another to ensure product quality. Read More

Indian Authorities Suspend Exports From Troubled Ranbaxy Facility

Indian authorities quietly suspended Ranbaxy’s Toansa facility from exporting active pharmaceutical ingredients to Europe late last month, signaling the country’s new, tougher approach to manufacturing quality violations. Read More

Pfizer Settles for $190M in Alleged Generic Delay Class Action Suit

Pfizer Monday reached an agreement to settle a class action lawsuit alleging that the drugmaker attempted to improperly delay the launch of generics of its epilepsy drug Neurontin. Read More

Steel Particles in Hospira Anesthetic Trigger Recall

Hospira’s quality struggles continue as the injectable giant voluntarily recalled seven lots of generic anesthetic propofol due a defect that led to metal particles in certain vials. Read More

EMA Ratchets Up Stability Data For Active Substance Changes

The European Medicines Agency is tightening stability testing requirements for drugmakers submitting applications for significant post-approval manufacturing changes that involve active substances. Read More

Guidance on Reporting Medication Errors on Target for 2015: EMA

The European Medicines Agency will publish a guideline next year specifying how drugmakers to code and share medication errors with regulators. Read More

Indian Manufacturer Recalls Generics Due to Mix-Up

Glenmark Generics, U.S. subsidiary of India-based Glenmark Pharmaceuticals, has recalled a lot of generic ranitidine 150 mg tablets after a pharmacist complained that a bottle of the drug contained 50 mg metoprolol tartrate tablets instead. Read More