January 27, 2015

Rep. Jason Chaffetz, R-Utah, last week introduced a bill that would extend to new combination drugs containing molecules already approved by the Food and Drug Administration the same five-year market exclusivity as a drug product containing an entirely new set of active ingredients.

January 20, 2015

Spurred by market opportunities, short-term market exclusivity for some newly launched single-source generics and rising costs for manufacturing, quality control and raw materials, me-too drug manufacturers have escalated a series of price hikes, some of them significant.

January 16, 2015

Kathleen "Cook" Uhl on Thursday was named director of the Food and Drug Administration's Office of Generic Drugs.


January 9, 2015

Teva Pharmaceuticals on Friday announced the launch of linezolid injection, the generic equvialent to Zyvox injection from C.P. Pharmaceuticals.

January 7, 2015

The pharmaceutical industry is back. Fueled by the launch of expensive, new biotech medicines, rising prices for both branded and generic drugs and a recent slowdown in branded-drug patent expirations and generic competition, the U.S. pharmaceutical market is staging a remarkable resurgence.

January 6, 2015

Vermont Attorney General Bill Sorrell is investigating generic drug price inflation.

December 29, 2014

In a staff memo, the Office of Generics Drug’s acting director, Kathleen Uhl, vowed to take action on 90% of the abbreviated new drug application backlog before October 2017, and has appointed Ted Sherwood as acting director of OGD’s Office of Regulatory Operations to help with the improvements, FDANews.com has reported.

December 18, 2014

The U.S. Senate Special Committee on Aging unveiled a new bipartisan report earlier this week that focuses on ways to increase the use of generic drugs within the Medicare Part D program.

December 17, 2014

The Generic Pharmaceutical Association on Wednesday expressed concerns that the current structure of the Trans-Pacific Partnership agreement (TPP) will impede generic utilization.

December 11, 2014

After a recent spike in the prices charged for some generic drugs led to outcries from pharmacists, patient advocates and federal lawmakers, a report issued last month suggests that drug costs can be controlled if the Food and Drug Administration changes the way it handles reviews and approvals.

December 11, 2014

Teva Pharmaceuticals on Thursday announced the availability of levalbuterol inhalation solution, USP (concentrate), a generic equivalent to Xopenex inhalation solution concentrate. 

December 10, 2014

Teva Pharmaceutical Industries on Wednesday announced the launch of generic Celebrex (celecoxib) capsules in the United States. The company is offering the capsules in 50-,100-, 200- and 400-mg dosage strengths. 


December 9, 2014

Reps. Doug Collins, R-Ga., and Dave Loebsack, D-Iowa, introduced on Tuesday H.R. 5815 — the Generic Drug Pricing Fairness Act — which creates greater transparency in how PBMs reimburse pharmacies for generic prescription drugs under Medicare Part D, the military’s TRICARE program, and the Federal Employees Health Benefits Program.

December 5, 2014

The FDA issued a draft guidance that would provide generic companies a pathway to obtain samples of medicines requiring a Risk Evaluation and Mitigation Strategy (REMS) protocol for product testing.

December 2, 2014

The Generic Pharmaceutical Association on Tuesday announced that it has named Terry Bazyluk as VP communications, effective Dec. 1, 2014. Bazyluk has served in senior communications roles for trade associations, corporate CEOs and presidential cabinet secretaries Madeleine Albright, Colin Powell and Robert Reich.

December 2, 2014

Teva Pharmaceuticals on Monday announced the introduction and availability of Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablets, CIII.

November 20, 2014

The Generic Pharmaceutical Association on Thursday emphasized the savings generic medicines bring to the table in light of rising brand prices. 

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.