Content about Pharmaceuticals policy

WASHINGTON The Food and Drug Administration should ensure patient access, safety and efficacy; create a transparent and scientific regulatory structure; and enable innovation and competition when creating regulations governing follow-on biologics, according to testimony released in advance of an FDA hearing by a drug lobbying group.

NEW YORK Risks of counterfeiting, contamination and intellectual property theft could increase with the globalization of the pharmaceutical supply chain, according to a new report.

SAN DIEGO The Food and Drug Administration declined to approve a regulatory approval application from Arena Pharmaceuticals and Eisai for a drug to treat obesity, the two companies said Saturday.

The FDA issued a complete response letter for the drug lorcaserin, designed for weight management and weight loss in patients who are overweight or obese and have at least one co-morbid condition. The FDA issues a complete response letter when it finishes reviewing an approval application, but issues remain that preclude final approval.

NEW YORK Speculation has emerged that Eli Lilly may seek to acquire several other companies in light of its difficulties winning approval for a long-acting diabetes treatment, according to published reports.

ST. LOUIS K-V Pharmaceutical has created a new marketing subsidiary for generic drugs, the company said Wednesday.

K-V announced the establishment of Nesher Pharmaceuticals, appointing as its president Mark Hartman, who has had several positions in generic drug companies.

BETHESDA, Md. The Food and Drug Administration could decide that some generic drugs are not equivalent to their branded counterparts, according to published reports.

CHARLESTON, S.C. Drug maker Purdue Pharma has donated $200,000 to the National Association of State Controlled Substances Authorities to address the abuse of prescription drugs, NASCSA said Tuesday.

The grant, presented at the group’s annual conference in Charleston, S.C., is designed to support state prescription drug monitoring programs. The NASCSA will be in charge of distributing the money to state agencies. Purdue is the maker of OxyContin (oxycodone), a commonly abused prescription opioid painkiller.

JERUSALEM The Food and Drug Administration granted approval for Teva's abbreviated new drug application to market a generic version of a drug designed to treat peptic ulcers.

The generic drug maker said that its drug, lansoprazole, is a generic version of Takeda’s Prevacid SoluTab. Annual sales of the branded product were approximately $453 million in the United States, according to IMS sales data.

Sandoz, the generics division of Swiss drug maker Novartis, also announced the launch of its own version of Prevacid SoluTab.

MORRISTOWN, N.J. The Food and Drug Administration has approved a Watson Pharmaceuticals generic drug for treating high blood pressure, Watson said Friday.

The company announced the FDA approval of amlodipine besylate and benazepril capsules in the 5/20-mg, 10/20-mg, 2.5/10-mg and 5/10-mg strengths.

The drug is a generic version of Novartis’ Lotrel. Branded and generic versions of the drug had sales of around $1.05 billion during the 12-month period ended in June, according to IMS Health.