Generic Line

The FTC Thursday asked the Supreme Court to take up and overturn an 11th Circuit Court’s decision that upheld the legality of reverse patent settlements between branded drug makers and generic competitors.

The FDA has outlined the requirements that drugmakers submitting Type II active pharmaceutical ingredient (API) drug master files (DMF) must meet before the files are listed on the agency’s public website as available for reference to support an ANDA.

Teva and Impax have ceased shipping their 300-mg generic of GlaxoSmithKline’s antidepressant Wellbutrin XL following an FDA determination that the drug is not therapeutically equivalent to its branded counterpart.

Generic-drug makers must submit self-identification information to the FDA by Dec. 3 to comply with the recently passed Generic Drug User Fee Amendments of 2012.

Generic companies should modify quality agreements and purchase orders with suppliers to ensure their business partners are following requirements of the new generic drug user fee amendments (GDUFA), industry experts urge.

ANDAs that lack basic quality-by-design (QbD) elements will be categorized as requiring “major” amendments and more extensive FDA consideration, according to a new Manual of Policies and Procedures (MAPP) for reviewers in CDER’s Office of Generic Drugs (OGD).

An Indian panel of government ministers has recommended price controls be applied to all 348 generic drugs on the country’s essential generic drug list.

The FDA is considering elevating staff that deals with drug shortages from the Office of New Drugs to the Office of the Center Director, the agency says.

The European Medicines Agency (EMA) will soon allow biosimilars sponsors to reference biologics made outside the European Economic Area (EEA) in some preclinical and clinical studies required for approval.

Apotex is taking the FDA to court for failing to grant timely approval of its ANDAs for two Sanofi hypertension treatments, Avapro and Avalide.

Endo Pharmaceuticals is petitioning the FDA to require that generic-makers referencing its crush-resistant pain drug Opana ER CRF demonstrate their products are similarly crush-resistant.

Mylan is suing the FDA over its refusal to grant 180-day exclusivity for the company’s four generic versions of Novartis’ high blood pressure drug Diovan.