Generic Line

Due to the holidays, Generic Line will not be published Dec. 21. The next issue will be published Jan. 4.

Ranbaxy won an eleventh-hour approval for generic Lipitor and is pairing with Teva to produce the cholesterol-lowering blockbuster.

U.S. Supreme Court Justices sharply questioned drug industry attorneys Monday as the court prepares to define the FDA’s authority in accepting and challenging brand drugmakers’ patent use codes for products.

A final FDA guidance allows generic-drug makers to remove a drug’s risk evaluation and mitigation strategy (REMS) if the reference drug’s REMS has been removed.

Drugmakers need incentives from Congress and the FDA to create improved manufacturing methods that would help alleviate ever-increasing drug shortages, an industry expert tells lawmakers.

Boehringer Ingelheim’s (BI) Ben Venue Laboratories is voluntarily suspending manufacturing in Bedford, Ohio, after an internal review found some equipment is overdue for preventive maintenance and requalification.

Three senators sent a letter to Pfizer requesting documents on its deals with pharmacy benefit managers and insurance companies to limit sales of generic Lipitor while promoting the brand drug.

As the dust settles after fall passage of patent overhaul legislation, one expert points to small victories generic-drug makers may draw from the changes.

The FDA warned Jenahexal, a Jena, Germany-based subsidiary of Sandoz, for marketing four unapproved homeopathic injectable drugs and for current good manufacturing practice (cGMP) violations, including inadequate aseptic procedures.

The FDA has granted a Warner Chilcott citizen petition, agreeing not to approve generic versions of the company’s ulcerative colitis drug Asacol that do not meet bioequivalence standards using in vitro dissolution and comparative pharmacokinetic (PK) data.

Takeda Pharmaceuticals is suing Hetero Drugs and two subsidiaries to bar them from marketing generic versions of Type 2 diabetes drug Actos.

Amphastar and Watson Pharmaceuticals are again appealing a federal court’s decision to uphold an injunction barring them from selling generic versions of Sanofi’s blockbuster blood-thinner Lovenox.

Mylan is moving further into the dry-powder inhaler platform arena as the generic-drug maker struck a deal with Pfizer to develop new brand and generic products.

The FDA has warned Mylan’s Caguas, Puerto Rico, facility for current good manufacturing practice (cGMP) violations, including a lack of specification testing, for finished drug products.

The FDA’s rigorous new bioequivalence roadmap for Salix Pharmaceuticals’ diarrhea drug Xifaxan and the antibiotic’s long-term patents likely mean scant drugmaker interest in pursuing a generic anytime soon, according to a Wall Street analyst.

Mylan will launch a generic version of Novartis Pharmaceuticals’ estrogen patch Vivelle-Dot on Dec. 16, 2013, under a settlement reached between the companies.

Recent feedback from FDA quality control consultants suggests the manufacturing problems bedeviling Hospira, particularly at its Rocky Mount, N.C., plant, will take two to three years to resolve and force the FDA to issue a stock-shocking consent decree, a Wall Street analyst says.

A federal appeals court has affirmed a lower court decision invalidating Teva’s stabilizing formulation patent for blockbuster AstraZeneca cholesterol drug Crestor.