Generics

LAKE FOREST, Ill. — Generic drug maker Hospira has joined the country's largest lobby for the generic drug industry, the company said.

Hospira, which specializes in generic injectables and infusion technology, announced that it had joined the Generic Pharmaceutical Association. In addition to generic pharmaceuticals, the company also makes biosimilars for the European market.

PITTSBURGH — The Food and Drug Administration has given tentative approval to a division of Mylan for a generic drug for treating HIV and AIDS in children in developing countries.

Mylan said Thursday that the FDA had tentatively approved Mylan Labs' abacavir sulfate and lamivudine tablets in the 60 mg/30 mg strength. The drug is a generic version of Viiv Healthcare's Epzicom and was approved under the President's Emergency Plan for AIDS Relief. The drug will only be available for purchase in certain developing countries outside the United States.

WASHINGTON — The president of one of the world's largest generic drug manufacturers will serve as chairman of the Generic Pharmaceutical Association, the organization said Thursday.

PORTLAND, Ore. — Prescription-only pseudoephedrine regulation has no impact on the methamphetamine trade, according to a Cascade Policy Institute study on the 2005 Oregon law, which restricts access to medicines containing pseudoephedrine.

WASHINGTON — The Food and Drug Administration's action to address the ongoing shortage of certain cancer drugs has garnered praise from a group representing the manufacturers and distributors of generic pharmaceuticals.

The Generic Pharmaceutical Association said it applauded the FDA's action to address the shortage of cancer drugs Doxil (doxorubicin hydrochloride liposome injection) and preservative-free methotrexate. GPhA also added that generic drug manufacturers are tirelessly working with regulators to provide needed supplies of the critical medicines.

NEW YORK — Pfizer has signed a deal worth more than $500 million with a Chinese drug maker to make generic drugs for China and other markets, the companies said.

Pfizer announced the joint venture with Zhejiang Hisun Pharmaceutical to develop, manufacture and commercialize generic drugs. Hisun will invest $295 million into the venture — called Hisun Pfizer Pharmaceutical Co. — and own a 51% stake, while Pfizer will invest $250 million and own 49%.

MUMBAI, India — A division of Pfizer is asserting that it incurred nearly $1 billion in damages related to the launch of generic versions of one of its drugs.

In a lawsuit filed in the U.S. District Court for the District of New Jersey against Sun Pharmaceutical Industries and Teva Pharmaceutical Industries, Wyeth Pharmaceuticals said it estimated that it suffered damages of $960 million from Sun's and Teva's launches of generic versions of the gastroesophageal reflux disease drug Protonix (pantoprazole).

PITTSBURGH — Mylan on Friday announced that the company and its subsidiary, Mylan Pharmaceuticals, have resolved the defamation and other related litigation filed by Mylan against the Pittsburgh Post-Gazette and two of its reporters.

"The litigation has been resolved to the satisfaction of both parties," the parties said in a joint statement. "The Post-Gazette did not find and did not intend to report that Mylan had manufactured or distributed any defective drugs. The Post-Gazette regrets if any reader of the article thought otherwise."