July 16, 2012

A subsidiary of Par Pharmaceutical Cos. acquired earlier this year has received its first Food and Drug Administration approval.

July 16, 2012

Is the reauthorization of the Prescription Drug User Fee Act “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act?”

July 13, 2012

The main office of the Food and Drug Administration in charge of regulating generic drugs has appointed a new director, the agency said Friday.

July 13, 2012

Nearly 200 drugs for mental illnesses are under clinical development or under review by the Food and Drug Administration, the largest lobbying group for the drug industry said Thursday.

July 12, 2012

The Food and Drug Administration has approved a generic drug for arthritis made by Watson Pharmaceuticals, the company said.

July 12, 2012

While most of the attention to the Prescription Drug User Fee Act reauthorization focused on what it would mean for the generic drug industry, one other aspect of the law recently drew applause from a group that advocates on behalf of the blind.

July 10, 2012

President Barack Obama signed into law Monday what some called a "historic" reauthorization of the Prescription Drug User Fee Act.

July 10, 2012

Generic drug maker Mylan is suing Warner Chilcott and an Australian company, alleging that they illegally tried to protect one of their drugs from generic competition, according to published reports.

July 5, 2012

Actavis has received a preliminary approval for a generic drug for treating high blood pressure, the drug maker said Thursday.

July 5, 2012

As states grapple with tight budgets, rising Medicaid costs and the anticipated expansion of Medicaid following the Supreme Court's decision to uphold the Patient Protection and Affordable Care Act, policymakers should consider how community pharmacists can help reduce expenses. In addition, new evidence offers a fresh reminder of the perils of managed care in Medicaid and the need for proper oversight of managed care entities.

June 28, 2012

A drug maker and a branch of the National Education Association have released a set of education resources designed to curb prescription drug abuse and misuse.

June 27, 2012

The Food and Drug Administration has approved an acne treatment made by Perrigo, the drug maker said Wednesday.

June 26, 2012

Generic drug maker Watson Pharmaceuticals is challenging the patent protection on an antidepressant made by Pfizer, the company said.

June 22, 2012

A drug maker has resubmitted its new drug application to the Food and Drug Administration for an acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

June 21, 2012

The leader of the country’s largest privately owned specialty pharmacy provider had a day in Washington.

June 21, 2012

Faced with the possibility of a critical cutoff in funding for the Food and Drug Administration, Congress moved in late May to reauthorize the Prescription Drug User Fee Act that provides the bulk of the agency’s resources for new-drug review and approval. 


June 20, 2012

The National Association of Chain Drug Stores on Wednesday urged Congress to pass the Prescription Drug User Fee Act, legislation essential to the review process for new medications and that also contains important pro-patient, pro-pharmacy provisions.

June 15, 2012

Upsher-Smith wins 2012 DIANAs in Branded Pharmaceutical Product Manufacturer and Consumer Product Manufacturer categories.

June 14, 2012

In healthcare technology circles, e-prescribing is among today’s hottest topics. A vital component of patient-centered care, it creates a connectivity platform that encourages collaboration between the physician and pharmacist who are in joint pursuit of an enhanced patient experience.

June 13, 2012

As the U.S. Senate and House reconcile their versions of the Prescription Drug User Fee Act, the National Association of Chain Drug Stores on Wednesday urged U.S. House and Senate leaders to expand provisions in the final bill to help ensure that Americans continue to have access to safe and effective prescription medications, while also curbing prescription drug abuse.

June 11, 2012

With overwhelming support in both the U.S. House and Senate and the strong backing of President Obama, a reauthorization of the landmark Prescription Drug User Fee Act that funds new drug application reviews at the Food and Drug Administration is a near certainty, probably within days or weeks at most. But one amendment to the Senate's version of PDUFA reauthorization, contained in the Food and Drug Administration Safety Innovation Act, could threaten both retail pharmacies and the patients they serve.

June 11, 2012

The state of New York is looking to become a national leader in curbing prescription drug abuse.

June 7, 2012

Government authorities are working to educate independent pharmacy owners on prescription drug abuse, an independent pharmacy network said.

June 6, 2012

A generic drug maker in India and a German pharmaceutical company will collaborate to develop biosimilars.