PHARMACY

Dey, Takeda settle suit with Alabama for combined $6.75 million

BY Drew Buono

NAPA, Calif. Dey and Takeda Pharmaceuticals have settled lawsuits with the State of Alabama, who brought suits against them and other companies in January 2005 related to Medicaid reimbursements paid by the state to pharmacists and other health care providers.

Dey has agreed to pay the state $4.75 million, $750,000 of which accounts for outside legal fees and expenses in exchange for a full release of claims in relation to drugs prescribed for pulmonary diseases and asthma. This settlement does not constitute an admission of guilt or liability by Dey.

As part of the agreement between Mylan, Dey’s parent company, and Merck, Dey’s former parent company, Merck has agreed to compensate Mylan in connection with the settlement and for all liability for all pending and future related Medicaid reimbursement lawsuits involving Dey.

The state’s claims against Takeda involved the diabetes drug Actos. Takeda has agreed to pay $2 million to the state.

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Study shows positive results from adding Lipitor early to blood pressure treatment

BY Drew Buono

NEW YORK According to a new study, when Lipitor was added as an early treatment to lower blood pressure, the drug showed a 36 percent reduction in the risk of fatal or non-fatal heart attacks over five years.

The study, entitled Anglo-Scandinavian Cardiac Outcomes Trial, was conducted over a five-year period in Europe with over 19,000 patients, with the first three years being dedicated to comparing Lipitor, a Pfizer product, with a placebo. The additional two years were used for post-study follow up. At the start of the study, patients had high blood pressure and additional cardiovascular risk factors but no coronary heart disease.

“This study highlights the importance of initiating medical treatment for both blood pressure and cholesterol as soon as possible, and raises questions about medical guidelines that do not focus on early intensive treatment of multiple risk factors, notably blood pressure and cholesterol, in patients with moderate cardiac risk,” according to Bryan Williams, chairman of the British Hypertension Society Guideline working party and professor of medicine, University Hospitals NHS Trust, Leicester, United Kingdom.

Patients in ASCOT-LLA had normal to mildly elevated cholesterol levels, were not candidates for lipid-lowering treatment at the time of the study initiation, and received Lipitor 10 mg or a placebo at the outset of the trial.

At the end of the follow-up period, LDL-C or bad cholesterol levels were similar in both groups as a result of Lipitor treatment and the average blood pressure level was significantly reduced from 164/95 mmHg to 137/78 mmHg with the blood pressure lowering therapy.

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Taro submits Flo-Pred application to FDA in new PLR format

BY Adam Kraemer

WASHINGTON Taro Pharmaceuticals applied Thursday to the Food and Drug Administration seeking approval for its new oral solution, Flo-Pred.

Flo-Pred (prednisolone acetate oral suspension) is an anti-inflammatory or immunosuppressive agent indicated for a variety of diseases and conditions, including allergic, dermatologic, gastrointestinal and hematologic. 

The medication also enjoys the distinction of—pending approval—being the first oral steroid label in the FDA’s new physician labeling rule format. The PLR format, which went into effect June 19, requires new content, new structure and new highlights information, as compared to the former structured product labeling.

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