Generics

PRINCETON, N.J. — The Food and Drug Administration has approved a generic contraceptive made by Sandoz, the company said.

Sandoz, the generics arm of Swiss drug maker Novartis, announced the FDA approval of Introvale (levonorgestrel and ethinyl estradiol), a generic version of Duramed’s Seasonale.

Branded and generic versions of Seasonale had sales of around $91 million during the 12-month period ended in November, according to IMS Health.

SAN DIEGO — The Food and Drug Administration has accepted the approval application for a chemotherapy drug to treat lung cancer from AdventRx Pharmaceuticals, the drug maker said Thursday.

The FDA accepted AdventRx’s application for Exelbine (vinorelbine). The drug is a branded generic, being formulated with the same active ingredient as Navelbine, originally marketed by French drug maker Pierre Fabre and now available as a generic from seven companies.

IRVINE, Calif. — A U.S. biotech company plans to develop a biosimilar of a monoclonal antibody used to treat cancers and autoimmune disorders.

Spectrum Pharmaceuticals announced Wednesday a deal with Viropro to develop a biosimilar rituximab, marketed under the brand name Rituxan by Roche’s Genentech division. Global sales of rituximab in 2009 were $5.6 billion, according to Spectrum.

NEW YORK — A generic version of the world’s top-selling cholesterol treatment is expected to hit the market this year, but the branded version’s manufacturer is trying to put the brakes on the launch, according to media reports.

Gurgaon, India-based Ranbaxy Labs plans to launch its version of Pfizer’s cholesterol-lowering drug Lipitor (atorvastatin) in the United States in November and will receive six months’ market exclusivity in which to compete directly against Pfizer’s version, under the terms of the Hatch-Waxman Act of 1984.

ALEXANDRIA, Va. — It’s a battle that raged for more than three years. But in mid-December, the retail pharmacy industry was able to declare a clear, unequivocal victory.


We’re talking, of course, about the struggle to head off what would have been a devastating change in the way Medicaid pays community pharmacies to dispense generic drugs to low-income patients. On Dec. 14, the chain and independent pharmacy lobbies announced they had reached a landmark agreement with the 
Centers for Medicare and Medicaid Services that effectively ends the threat.

WOODCLIFF LAKE, N.J. — Generic drug maker Par Pharmaceutical has begun shipping its version of a treatment for heart rhythm problems, the company said Monday.

Par announced the shipment of propafenone SR capsules, a treatment for atrial fibrillation in patients without structural heart disease.

The drug is a generic version of GlaxoSmithKline’s Rhythmol SR, which has annual sales of around $121 million, according to IMS Health.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical has started shipping a generic version of a hypertension drug, the company said Monday.

Par announced the shipment of amlodipine besylate and benazepril hydrochloride capsules in the 5-mg/320-mg and 10-mg/320-mg strengths. The drug is a generic version of Novartis’ Lotrel, which has annual sales of $361 million in the two strengths, according to IMS Health.

PITTSBURGH — Generic drug maker Mylan has settled a lawsuit concerning Medicaid reimbursements with the federal government and the state of Texas, Mylan said Dec. 24.

Under the settlement, Mylan will pay $65 million.

Several state attorneys general filed lawsuits against Mylan and other drug companies in September 2003 over Medicaid reimbursements, alleging that the companies defrauded the programs by reporting average wholesale prices greater than the prices of their prescription drugs, thus causing the programs to make excessive payments to healthcare providers.