September 16, 2013

The Food and Drug Administration is barring the importation of drugs from another one of Ranbaxy Labs' plants in India, the agency said Monday.

September 12, 2013

The news that the Food and Drug Administration exceeded its hiring goals for a push that began last year to speed up review of generic drug approval applications is music to the ears of a trade group representing the industry.

September 11, 2013

The Food and Drug Administration has exceeded its goals for hiring new staff as part of a user-fee law for generic drugs, according to an internal memo sent to staff members.

September 10, 2013

The Food and Drug Administration is raising the fees that generic drug companies will have to pay when filing for regulatory approval for new products or supplemental applications for existing products, the agency said last month.

September 10, 2013

A new set of guidelines from the Food and Drug Administration could bring a generic version of a respiratory drug made by GlaxoSmithKline closer to reality.

September 10, 2013

While the U.S. generic drug market has grown at a rapid pace, the international market for generic manufacturing and use has grown as well.

September 10, 2013

One trend that generic companies and pharmacy retailers alike should keep an eye on is the patent cliff.

September 10, 2013

Drug maker Depomed has expanded the geographic scope of a license agreement it has with Merck for diabetes drugs, the company said.

September 10, 2013

Generic drugs have been on a roll with their share of total prescriptions dispensed in the country seeming to increase on a nearly constant basis. But it appears the peak is coming soon.

September 10, 2013

Teva Pharmaceutical Industries has introduced a generic version of an antibiotic drug kit, the company said.

September 3, 2013

Over the last few years, many drug makers have offered coupons and co-payment-assistance programs as a way to reduce patients' out-of-pocket spending on medications, but a new study questions whether they really reduce spending in the long run and whether they're even legal.

August 28, 2013

The global market for drug packaging is expected to experience tremendous growth over the next few years, according to a new report.

August 27, 2013

AstraZeneca has bought Maryland-based biotech company Amplimmune, the drug maker said.

August 27, 2013

Lawmakers in California have passed a bill that would restrict the use of follow-on versions of biotech drugs known as biosimilars, according to published reports.

August 26, 2013

Biotech company Amgen is buying Onyx Pharmaceuticals, the companies said Sunday.

August 20, 2013

The Food and Drug Administration has approved a generic drug for depression made by Par Pharmaceutical, the drug maker said.

August 20, 2013

Generic drug maker Sandoz has relaunched a website to promote its biosimilars business.

August 20, 2013

A variety of macroeconomic factors are driving growth in the generic drug market in Southeast Asia.

August 13, 2013

The U.S. Food and Drug Administration this past weekend announced new fee rates for fiscal year 2014, including the abbreviated new drug application fee.

August 12, 2013

Perrigo Co. announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug applications for fluocinolone acetonide scalp oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Scalp Oil, and fluocinolone acetonide topical oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Body Oil.

August 8, 2013

Can one of the nation's premier specialty pharmacies maintain its focus on each patient it serves while simultaneously smashing its own growth records and reaching national power-player status in the rarified world of specialized medication services?

August 8, 2013

For traditional retail pharmacies, one of the biggest roadblocks to entry into the specialty arena is the limited availability of many complex medicines.

August 8, 2013

The world is turning generic. That's the takeaway from the latest trends in the drug industry, according to IMS Health.

August 8, 2013

The Supreme Court usually has a lot on its plate in any given year, but this year's term included a pretty big case for the pharmaceutical industry: the Federal Trade Commission v. Actavis, which concerned legal settlements between branded and generic drug makers that often occur when the latter attempts to market a generic drug before the former's patents have expired.