Content about Pharmacology

BRIDGEWATER, N.J. — U.S. generic drug maker Amneal Pharmaceuticals has entered a deal with South Korean drug maker Hanmi Pharmaceutical to acquire exclusive distribution rights for a Hanmi drug used for treating gastroesophageal reflux disease, Amneal said Monday.

CAMBRIDGE, Mass. — The Food and Drug Administration has accepted a regulatory approval application from Genzyme for an experimental treatment for multiple sclerosis, the company said Monday.

Genzyme, a division of French drug maker Sanofi, said the FDA accepted its application seeking approval for Lemtrada (alemtuzumab) for relapsing MS. The company expects the agency to decide whether to approve the drug in the second half of this year.

Health care is evolving. As obvious of a statement as that is, it doesn’t change the fact that it is very real. Throughout last year, there was intense discussion on the Patient Protection and Affordable Care Act and what impact the outcome of the presidential election might have on its future. Now that the Supreme Court has ruled and elections are settled, healthcare companies and providers across the country are implementing strategies to meet ACA requirements.

NEW YORK — Canada's provincial and territorial governments have reached a deal that they said would save money on drugs, but that generic drug makers said had left them "disappointed."

WHITEHOUSE STATION, N.J. — Merck on Friday announced the Food and Drug Administration has approved the switch of Oxytrol for Women (oxybutynin transdermal system, 3.9 mg/day) from prescription-only to nonprescription, creating a new category — overactive bladder in women — in the OTC area. Most notable about this switch is the fact that the FDA approved Oxytrol for Women against the majority opinion of its Nonprescription Drug Advisory Committee, which voted five in favor and six opposed to the switch in November. 

ADA, Ohio — Students at an Ohio pharmacy school are taking part in a nationwide effort to boost medication adherence.

Ohio Northern University announced that the school's chapter of the American Pharmacists Association — Academy of Student Pharmacists — had scheduled several events as part of the Medication Adherence Challenge, sponsored by the American Association of Colleges of Pharmacy.

ALEXANDRIA, Va. — Seniors have serious concerns regarding mandatory mail-order pharmacy requirements in prescription drug plans, according to a new national survey of 669 Medicare Part D beneficiaries released Thursday by the National Community Pharmacists Association.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for removing excess iron from the blood in patients with a rare genetic disorder, the agency said.

The FDA announced the approval of Novartis' Exjade (deferasirox) for patients ages 10 years and older with chronic iron overload resulting from nontransfution-dependent thalassemia, or NTDT. A companion diagnostic, FerriScan, made by Australia-based Resonance Health, also was approved.

SCHLIEREN, Switzerland — Cytos Biotechnology will regain rights to an experimental vaccine against nicotine addiction that it had licensed to Novartis, Cytos said Wednesday.

The company said that Novartis would discontinue the project, known as NIC002. Cytos granted Novartis a license for NIC002 in 2007, but phase-2 trial results in October 2009 indicated that the vaccine spurred the development of nicotine-specific antibodies in patients, but did not increase smoking cessation.

ATLANTA — The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.

ALLEGAN, Mich. — Perrigo on Tuesday announced that it has begun shipments of over-the-counter nicotine polacrilex mini lozenge USP, 2 mg (mint flavor) and 4 mg (mint flavor), comparable to GlaxoSmithKline's Nicorette mini lozenge. 

"This launch strengthens Perrigo's leading store brand position in smoking cessation products, which also includes coated and uncoated flavored gums and regular size lozenges," stated Joseph Papa, Perrigo's chairman, president and CEO. 

NEW YORK — While regulations for biosimilars work their way through the Food and Drug Administration, state governments are already looking at legislation concerning the substitution of biosimilars for their branded counterparts, according to a legal affairs blog focused on the FDA.

In a post Friday on FDA Law Blog, the official blog of the law firm Hyman, Phelps & McNamara, attorney Kurt Karst wrote that several states were laying the groundwork for such legislation, recalling state-level antisubstitution laws targeting generics that were adopted in the 1970s.