November 19, 2014

The Food and Drug Administration opened a public docket and requested comments on proposed criteria for “first generic” abbreviated new drug application submissions.

 

November 17, 2014

DSN spoke with Neas in late October to mark the 30th anniversary of the landmark Drug Price Competition and Patent Term Restoration Act — better known as the Hatch-Waxman Act. 

November 17, 2014

Thirty years ago, Democratic and Republican members of Congress hammered out a rare and prescient bipartisan compromise bill that transformed the pharmaceutical landscape forever and unleashed the modern generic drug industry. That law, known as the Hatch-Waxman Act, has proven to be one of the most far-reaching and impactful pieces of legislation ever to shape the American healthcare system.

November 11, 2014

Dr. Reddy's Labs received approval from the Food and Drug Administration for a generic version of Roche Holding's antiviral medication Valcyte, according to a Reuters report

October 31, 2014

Diabetes treatment with a low-cost generic drug can have significant, positive implications for a patient's quality of life and medication cost, according to new research from CVS Health.

October 28, 2014

Independent community pharmacies are increasingly providing services to support patient medication adherence and set a new record high in the proportion of prescriptions filled with typically lower-cost generic drugs.

October 24, 2014

In the wake of an Oct. 21 blogpost on Health Affairs, “The $500 Billion Medicare Slowdown: A Story About Part D,” Ralph Neas, president and CEO of the Generic Pharmacuetical Association, issued the following statement.

October 22, 2014

The Food and Drug Administration last week announced plans to survey pharmacists and patients about their experiences resulting from changes in generic drug pill appearance.

October 15, 2014

As the Food and Drug Administration begins to explore ways to improve its user-fee program for generic drugs, the Generic Pharmaceutical Association and its members have weighed in with suggestions on how to shore up the law to ensure that it helps bring generics to market faster and provides benefits across the entire healthcare system.

October 15, 2014

What’s in a name? A lot, apparently, if the name applies to a biosimilar medicine.

October 14, 2014

U.S. Sen. Bernie Sanders, I-Vt., and U.S. Rep. Elijah Cummings, D-Md., earlier this month launched an investigation into soaring generic drug prices.

October 14, 2014

Twenty African-American and Hispanic community and health care organizations earlier this month submitted a letter to the Food and Drug Administration raising concerns that its Proposed Rule on Generic Labeling could jeopardize patient safety and access to affordable medicines. 

September 30, 2014

Wholesaler H.D. Smith last week promoted Dmitrey Kuznetsov to VP generic pharmaceuticals. 

September 24, 2014

In honor of the 30th anniversary of the Drug Price Competition and Patent Term Restoration Act — more commonly known as the Hatch Waxman Act — which enabled manufacturers to bring generic versions of pharmaceuticals to market more easily, GPHA president Ralph Neas issued a statement.

September 24, 2014

In celebration of the 30th anniversary of the enactment of the Drug Price Competition and Patent Term Restoration Act, also known as the “Hatch-Waxman” Act, the National Association of Chain Drug Stores issued a statement to reflect on the evolution of providing patient access to generic medications and noted that it is looking forward to further progress in the years ahead.

September 23, 2014

A bill has been introduced that lawmakers say would “close federal loopholes” and increase consumer access to generic drugs while boosting market competition.

September 18, 2014

The Generic Pharmaceutical Association on Thursday provided input on the Generic Drug User Fee Act process before the Food and Drug Administration. 

September 15, 2014

A new study by researchers at CVS Health and Brigham and Women's Hospital found that patients who took a generic statin were more likely to be adherent to their medication than those starting on a branded drug.

September 10, 2014

The Generic Pharmaceutical Association on Wednesday released a report showing that generic drugs saved the United States health system $239 billion in 2013.

August 21, 2014

The generic drug industry — and by extension, patients across the United States — is being adversely impacted by what some are calling branded drug makers’ abuse of risk evaluation and mitigation strategies, or REMS.

August 21, 2014

Restricting access to samples of generic biological drugs would lead to nearly $140 million in lost savings for every $1 billion in biologics sales, Matrix Global Advisors said.

August 20, 2014

Despite creating a detailed plan to speed up the rate at which generic drug applications are reviewed, experts say a backlog has developed at the Food and Drug Administration’s Office of Generic Drugs.

August 18, 2014

The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities. 

August 14, 2014

Amneal Pharmaceuticals announced four new additions to its portfolio of generic drugs, which represent multiple therapeutic categories and account for $900 million annually in U.S. sales, the company said, citing data from IMS Health.