The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities.
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.
Teva Pharmaceutical Industries on Thursday announced that the U.S. Court of Appeals for the Federal Circuit upheld a ruling by the U.S. District Court for the District of Delaware finding Bristol-Myers Squibb's entecavir compound claim of U.S. Patent No. 5,206,244 invalid.
Valeant Pharmaceuticals International announced that its subsidiary, Valeant Pharmaceuticals North America, received approval from the Food and Drug Administration for its new drug application for Jublia (efinaconazole 10% topical solution). The drug is the first topical triazole approved for the treatment of onychomycosis of the toenails, the company said.
Mylan announced on Monday that it has entered into a settlement and license agreement with Pfizer relating to Mylan's abbreviated new drug application filed with the U.S. Food and Drug Administration for celecoxib capsules in 50-mg, 100-mg, 200-mg and 400-mg strengths.
Pfizer announced plans to submit a new drug application with the Food and Drug Administration for palbociclib, which is used for the first-line systemic treatment of post-menopausal women with advanced or metastatic breast cancer.
Perrigo on Monday announced that it received approval from the Food and Drug Administration for azelastine hydrochloride nasal spray (0.15%), a generic version of Astepro. The drug is indicated for people ages 12 years and older and is used to treat nasal symptoms brought on by seasonal allergies or environmental irritants.
Actavis earlier this week announced that it has entered into an agreement with Noven Pharmaceuticals to settle all outstanding patent litigation related to Actavis' generic version of Daytrana (methylphenidate transdermal system).
In a blog post updated Friday, Food and Drug Administration commissioner Margaret Hamburg addressed two challenges facing Indian drug manufacturers — approval times for abbreviated new drug applications and quality inspections.
The Nonprescription Drugs Advisory Committee announced it would meet February 25 to discuss data submitted by Armstrong Pharmaceuticals in support of a new drug application for the over-the-counter marketing of Primatene HFA.
When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.
For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.
The news that the Food and Drug Administration exceeded its hiring goals for a push that began last year to speed up review of generic drug approval applications is music to the ears of a trade group representing the industry.
The Food and Drug Administration is raising the fees that generic drug companies will have to pay when filing for regulatory approval for new products or supplemental applications for existing products, the agency said last month.