Content about Pharmacology

SILVER SPRING, Md. Drug maker Forest Pharmaceuticals will pay more than $300 million to the federal government as part of a plea agreement over alleged improper drug distribution and obstructing a Food and Drug Administration inspection.

WASHINGTON The Internal Revenue Service earlier this month issued guidance reflecting statutory changes regarding the use of certain tax-favored arrangements, such as flexible spending arrangements, to pay for over-the-counter medicines and drugs.

SWIFTWATER, Pa. The Food and Drug Administration has accepted a regulatory approval application for a flu vaccine administered in the skin.

Sanofi Pasteur, the vaccines arm of French drug maker Sanofi-Aventis, announced Monday that the FDA had accepted its application for Fluzone Intradermal (influenza virus vaccine). The company expects the FDA to take action on the vaccine in the first half of next year.

NEW YORK The federal government got a kick in the face Thursday as an appeals court ruled in favor of patent litigation settlements between branded and generic drug companies.

WHAT IT MEANS AND WHY IT’S IMPORTANT It’s about time.

(THE NEWS: NACDS, NCPA in joint statement praise CMS' move to withdraw provisions of AMP rule currently blocked by injunction. For the full story, click here)

AMITYVILLE, N.Y. Hi-Tech Pharmacal had $40.4 million in sales during its fiscal first quarter ended July 31, the generic drug maker said Thursday. The numbers amounted to a decrease of $3 million from the same period in 2009.

SAN DIEGO Drug maker Somaxon Pharmaceuticals has made its treatment for insomnia available by prescription, the company said Tuesday.

Somaxon announced the availability of Silenor (doxepin), which received approval from the Food and Drug Administration in March as a treatment for insomnia characterized by difficulty with sleep maintenance.

NEEDHAM, Mass. Pfizer is pulling out of a development deal for a potential brain cancer drug, saying it is not a strategic priority, according to the drug's developer Celldex Therapeutics.

Celldex said it will regain full worldwide rights to develop and sell rindopepimut from Pfizer. The drug candidate also is called CDX-110. In May, the company reported positive results form a midstage study on the drug.

Celldex will regain rights to the drug candidate on Nov. 1.

RICHMOND, Va. The Food and Drug Administration has approved Reckitt Benckiser’s treatment for opioid addiction, Reckitt Benckiser said.

The drug maker announced the approval of Suboxone (buprenorphine and naloxone), a drug delivered through a fast-dissolving film placed under the tongue. The film is based on a technology known as PharmFilm, made by MonoSol Rx.

SAN DIEGO Improving medication adherence will require bringing multiple methods together in order to be successful, Pharmacy Quality Alliance senior director for research and performance measurement David Nau said Tuesday in an education session at the National Association of Chain Drug Stores’ Pharmacy and Technology Conference in San Diego.

“You need to have a multifaceted strategy around adherence if you want to have an impact on adherence,” Nau said.

LONDON The Food and Drug Administration has pushed back its review date for a drug made by GlaxoSmithKline and Valeant Pharmaceuticals.

The FDA has not yet completed the review of the new drug application for ezogabine, a drug designed to treat epileptic adults with partial onset seizures, after a formal risk evaluation and mitigation strategy was submitted to the agency from GSK and Valeant, per its request.

The FDA is expected to review the application by Nov. 30.