Generics

WASHINGTON — Gov. Bob McDonnell of Virginia has signed into law the first bill that could limit the reach of follow-on biologics, though the bill includes a two-year sunset clause, meaning it will expire in 2015.

McDonnell signed House bill 1422 and the identical Senate bill 1285, which would prevent a pharmacist from dispensing a biosimilar to substitute for the original, branded biologic if the prescriber indicated that substitution was not allowed or if the patient insisted on receiving the branded product.

PRINCETON, N.J. — The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Estarylla (norgestimate and ethinyl estradiol tablets) and Tri-Estarylla (norgestimate and ethinyl estradiol tablets), generic versions of Johnson & Johnson's Ortho Cyclen and Ortho Tri-Cyclen, respectively. Sandoz said the launches brought the total number of oral contraceptives it has launched since the beginning of 2011 to six.

JERUSALEM — Teva Pharmaceutical Industries has appointed a former executive from Dyax to its executive team, the Israeli generic drug maker said.

Teva announced the appointment of Ivana Magovčević-Liebisch as SVP and head of corporate business development, effective April 1. Magovčević-Liebisch served as EVP and COO for Dyax, a Burlington, Mass.-based drug company.

SCHAUMBURG, Ill. — Generic drug maker Sagent Pharmaceuticals has appointed James Hussey as its president, the company said.

Sagent said the board of directors' appointment of Hussey, 53, would be effective Monday. Hussey will be responsible for the company's commercial operations, including development, regulatory affairs, supply chain activities, sales, marketing and human resources.

SILVER SPRING, Md. — The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said Tuesday.

In a memo sent out to staff of the Center for Drug Evaluation and Research, the section of the agency that oversees the OGD, CDER director Janet Woodcock wrote that Uhl most recently served as senior adviser to director Greg Geba, who announced his resignation Thursday.

WASHINGTON — The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.

PITTSBURGH — The Food and Drug Administration has approved a generic treatment for bronchospasm made by Mylan, the drug maker said Monday.

Mylan announced the approval of levalbuterol inhalation solution in the 0.31 mg/3 mL, 0.63 mg/3 mL and 1.25 mg/3 mL strengths. The company has begun shipping the product.

The drug is a generic version of Sunovion's Xopenex inhalation solution, which is used to treat bronchospasm in patients ages 6 years and older with reversible obstructive airway disease.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a drug for obsessive compulsive disorder made by Par Pharmaceutical Cos., the drug maker said Thursday.

Par announced the approval and shipment of fluvoxamine maleate extended-release capsules in the 100-mg and 150-mg strengths. The drug is a generic version of Jazz Pharmaceuticals' Luvox CR.