Generic Line

The FDA’s plan to require more stability data for ANDAs is likely to slow approvals unless the agency flexes a little, generic-drug makers say.

The FTC is challenging a GlaxoSmithKline (GSK)-Teva patent settlement deal, filing an amicus brief that argues authorized generic agreements fall under the category of pay-for-delay deals and are anticompetitive.

The FTC tentatively approved Watson Pharmaceuticals’ acquisition of Actavis, provided Watson transfers rights to 18 drugs to Sandoz and Par Pharmaceuticals and relinquishes manufacturing and marketing rights to three other products involved in the sale.

Ben Venue’s Bedford, Ohio, plant — in the news this past year for quality problems — has restarted a handful of production lines to make some of its critical-need drugs available again.

India’s Central Drugs Standard Control Organization (CDSCO) is reminding state regulators that generic drug manufacturing licenses should be granted using the generic name of the drug only.

Mylan can begin selling a generic version of Shionogi Pharma’s lung drug Orapred ODT in April 2014 or earlier under certain circumstances per an agreement with the brand drug’s maker.

Ranbaxy has been granted the right to intervene as a defendant in a lawsuit that could determine whether Ranbaxy or its generic competitor Mylan will get 180-day exclusivity for generic versions of Novartis’ Diovan.

The Supreme Court has declined to take up Allergan’s patent infringement case against Watson regarding the overactive bladder drug Sanctura XR, leaving Allergan vulnerable to generic competition.

Roche has been hit with a series of litigation setbacks as companies try to chip away at the exclusivity of Boniva, a once-monthly osteoporosis treatment.

The FDA has given $2.7 million to University of Cincinnati researchers to study whether generic versions of the transplant drug Prograf have the same efficacy as Astellas Pharma’s branded product.

Avanir Pharmaceuticals is initiating a second lawsuit against Impax Laboratories, alleging Impax’s ANDA for generic Nuedexta infringes on a new Avanir patent.