FDAnews Drug Daily Bulletin

ANDA filers that have submitted an application on or after Oct. 1 must pay $51,520 in user fees, according to the FDA’s 2013 generic drug user fee rates announced Wednesday.

The International Trade Committee last month narrowly endorsed a mutual recognition deal that would allow EU-certified medicines to be exported to Israel and vice-versa without requiring additional certification for the importing country.

The FDA has granted a priority review to Genentech’s sBLA for Avastin in people with metastatic colorectal cancer (mCRC) who have already been treated with chemotherapy plus Avastin.

Lupin Pharmaceuticals received final approval for its levonorgestrel and ethinyl estradiol tablets, USP 0.15 mg/0.03 mg, from the FDA to market a generic version of Teva Pharmaceuticals’ Seasonale tablets.

Macitentan, an investigational next-generation endothelin receptor antagonist for pulmonary arterial hypertension (PAH), met its efficacy endpoint and was well tolerated in a large clinical trial.

Tonix Pharmaceuticals has completed dosing and plasma analysis of a pharmacokinetic (PK) study of its TNX-102 sublingual tablet, a formulation of cyclobenzaprine for bedtime use.

A generic drugmaker has accused a British pharmaceutical company of putting profits ahead of patients in its efforts to block cheaper generic versions of Suboxone from coming on the U.S. market.

German authorities ordered a recall Thursday of some batches of Novartis flu vaccine as a precautionary measure, after the company reported the appearance of small particles in the manufacturing process.

AstraZeneca’s sales slumped by a bigger-than-expected 19 percent in the third quarter, underscoring the challenges confronting the drugmaker’s new chief executive, Pascal Soriot.