September 13, 2013

Companies that make long-acting opioid painkillers will be required to conduct studies to assess their safety, while use of the drugs will be restricted, under new requirements from the Food and Drug Administration.

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 country's embryonic biosimilars industry scored a victory last month as the organization that runs the pension fund for California state employees announced its opposition to a state Senate bill provision that would impose special requirements on pharmacists who dispense follow-on biologics.

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 5, 2013

Japanese drug maker Otsuka Pharmaceutical Co. is buying U.S.-based Astex Pharmaceuticals for $886 million, Otsuka said Thursday.

September 3, 2013

The Food and Drug Administration has approved a new vial size for a treatment for a rare immune system disorder.

September 3, 2013

Sage North America last week announced that it partnered with McKesson Pharmacy Systems & Automation, a division of McKesson, to help develop the McKesson Mobile Delivery application for prescription delivery services.

August 29, 2013

The Food and Drug Administration has approved the latest drug in BD's Simplist line, the company said Thursday.

August 29, 2013

The Food and Drug Administration is concerned about bills in several state legislatures that seek to restrict pharmacists' ability to dispense biosimilars, according to published reports.

August 28, 2013

The Food and Drug Administration has approved a drug made by Galderma Labs for treating a side effect of rosacea in adults, the company said.

August 26, 2013

The Food and Drug Administration approved a new drug made by Ceptaris Therapeutics for treating a type of lymphoma, the company said.

August 22, 2013

The Food and Drug Administration has approved a supplemental regulatory application from Mylan for a generic antidepressant that was subject last year to scrutiny by the agency amid reports of efficacy problems, Mylan said Thursday.

August 19, 2013

The Food and Drug Administration is looking to regulate flavored cigars, according to published reports.

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

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.

August 8, 2013

Keryx Biopharmaceuticals announced the submission of a new drug application to the Food and Drug Administration seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis.

August 6, 2013

The Food and Drug Administration has approved a generic heart disease drug made by Lupin, the Indian drug maker said.

August 1, 2013

Sanofi Wednesday evening announced that the Food and Drug Administration's Nonprescription Drugs Advisory Committee voted 10-6 in favor of its switch application of the nasal corticosteroid Nasacort AQ. Two committee members abstained.

July 31, 2013

The Food and Drug Administration has given Lupin Pharmaceuticals tentative approval to two of its products, the company said Wednesday.