Generic Line

The House voted 387-5 to pass its omnibus FDA user fee bill last week, giving lawmakers most of June to iron out differences between it and the version the Senate passed earlier in May.

FDA statistics show more than one-third of all drug recalls last year were due to stability failures — a figure that suggests the generic industry’s call for stability testing flexibility in a forthcoming guidance is unwarranted, agency officials say.

Rogue online pharmacies looking to cash in on drugs in short supply are peddling counterfeit versions of Teva’s generic attention-deficit/hyperactivity disorder drug Adderall, the FDA warns.

Pharma stakeholders are calling on the FDA to publish a list of critical drugs to help clarify what products fall under current requirements and possible future laws for drug shortage notification.

A Delaware federal judge has upheld two patents covering GlaxoSmithKline’s heart drug Lovaza.

Biosimilars’ molecular characteristics should mirror those of the reference biologic as closely as possible, while the performance and consistency of the biosimilars’ manufacturing process should stand on its own, the European Medicines Agency (EMA) says in updated guidelines.

A flood of Lipitor generics hit the market last week, but Teva, the world’s largest generic-drug maker, decided a better strategy is not to sell what was once the world’s best-selling drug — at least not yet.

To promote more thorough ANDA filings and faster reviews, the FDA’s Office of Generic Drugs (OGD) plans to extend its quality-based review (QbR) process to Type II drug master file (DMF) submissions, FDA officials say.

Generic-drug makers are contributing to review delays because, intentionally or not, their ANDAs too often fail to provide a full list of personnel and facilities involved in drug manufacturing and testing, FDA officials say.

Watson Pharmaceuticals could launch its generic version of Endo Pharmaceuticals’ pain patch Lidoderm (lidocaine 5%) on Sept. 15, 2003, if the drugmaker gains FDA approval.

Agency inspectors found Impax Laboratories failed to reject drug products that did not meet established standards and specifications, an FDA Form 483 states, shedding light on quality issues found at the company’s troubled Hayward, Calif., facility.