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April 9, 2014

Vol. 31
No. 8


Full Issue of Generic Line in PDF Format

Download and view the full issue. Read More

Industry Wants More Meetings, Guidance on ANDA Process

The FDA needs to hold more presubmission meetings with generic drugmakers on topics such as stability, batch size and drug release specifications to speed up the ANDA approval process, industry representatives say. Read More

House Panel Battles Over Proposed Generic Drug Labeling Rule

Republican lawmakers April 1 blasted CDER Director Janet Woodcock for the FDA’s consulting with trial attorneys and not brand or generic drugmakers when developing a controversial proposed overhaul of generic drug labeling rules. Read More

Teva Petitions SCOTUS for Stay of 2013 Copaxone Patent Ruling

Teva Pharmaceuticals asked U.S. Supreme Court Chief Justice John Roberts Tuesday to recall and stay a July 2013 appeals court ruling invalidating a patent on Teva’s blockbuster multiple sclerosis drug Copaxone, pending the full court’s final decision on the patent case. Read More

Brazil Requires Advance Notice of Drug Withdrawals

Drugmakers must now give Brazil’s ANVISA a full year’s warning before withdrawing a product from the market if the withdrawal could result in a drug shortage. Read More

EMA Reforms Will Speed Review of Type IA and IB Variations

Drugmakers seeking variations to marketing authorizations in the EU will now have a point person assigned to usher their applications through the evaluation process, the European Medicines Agency says. Read More

Mylan Sues Celgene to Gain Access to Branded Products

Mylan is accusing Celgene of violating federal antitrust law by prohibiting the generic drugmaker from obtaining samples of its blockbuster products Thalomid and Revlimid to make generic versions. Read More

Hospira Paying $60 Million To Settle Class-Action Suit

A federal court tentatively approved a $60 million payout by Hospira to end a class-action lawsuit that claimed the drugmaker misled investors about its quality problems. Read More

FDA Warns Indian API Maker For Blending Batches

The FDA chastised another Indian drugmaker for poor quality, this time warning active pharmaceutical ingredient manufacturer Smruthi Organics for not protecting raw data and blending out-of-specification batches of API with conforming batches. Read More

FDA Seeks More Immunogenicity Testing For Low Molecular Weight Heparins

The FDA wants manufacturers of low molecular weight heparin (LMWH) products to do a better job of assessing immunogenicity risk before submitting their products for approval. Read More

Swissmedic Narrows Approval Pathway For Heparin-Based Biosimilars

Unlike in the EU, Swiss regulators will not accept marketing authorization applications for biosimilars of low-molecular-weight heparin products already approved in Switzerland. Read More

Quality Revamp Brings West-Ward Warning Letter Close Out

The FDA has closed out a warning letter issued to West-Ward Pharmaceuticals after the generic drugmaker completed a two-year overhaul of parts of its quality system. Read More

Five Makers of High-Dose Acetaminophen Missed Product Removal Deadline

The FDA said Thursday that all manufacturers have voluntarily complied with an agency ban on selling acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet. Read More

EU Biotechs Push Back on Same-Name Biosimilars

The EU’s primary biotech lobbying group is pushing back against same-name biosimilars, arguing that physicians would find such a system confusing. Read More

Apotex Joins FDA’s India-Based Import Ban List, Pending Upgrades

The FDA has banned Canadian generics maker Apotex from importing drugs to the U.S. made at its Bangalore, India, site, pending quality upgrades. Read More