The year 2012 is coming to an end, and it's been a big year for generic drugs. It's the year that the most lucrative drug of all time became commoditized. It's the year that Watson bought Actavis for $5.6 billion. And it's the year the FDA released draft guidance for biosimilars regulations. All of these events speak to some of the most important trends in the world of generics — trends that are often interrelated.
UCB on Monday announced that the Food and Drug Administration has approved a supplemental new drug application for Vimpat (lacosamide) C-V as monotherapy in the treatment of partial-onset seizures in patients with epilepsy ages 17 years and older.
GlaxoSmithKline announced FDA approval for Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid medicine for the treatment of asthma in patients 12 years of age and older.
PharmaJet, the developer of a needle-free injection technology to administer medications and vaccines to patients, and bioCSL, the maker of Afluria (influenza vaccine) on Tuesday announced the Food and Drug Administration has approved the PharmaJet Stratis 0.5mL Needle-Free Jet Injector for delivery of Afluria in individuals ages 18 years to 64 years.
The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities.
The recent release of Colgate Total’s application submitted to the Food and Drug Administration, which included 35 pages summarizing toxicology studies on triclosan, is raising some eyebrows as some are wondering if the FDA did its due diligence in approving Total 17 years ago, according to a report from Bloomberg Businessweek.
The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act, Bloomberg BNA reported.
On June 25, the U.S. Department of Justice, at the request of the Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede of Rancho Dominguez, Calif., and its president, Michael Pellico.