February 4, 2011

A private entrepreneur is close to introducing a take-home intracervical insemination fertilization kit to retail, according to a story published in the Pittsburgh Post-Gazette Friday.

February 4, 2011

The Food and Drug Administration has approved a generic Alzheimer’s disease treatment from Sun Pharmaceutical Industries.

February 2, 2011

The Food and Drug Administration declined to approve a drug made by Eisai for treating gastroesophageal reflux disease, Eisai said Tuesday.

February 2, 2011

One of the more recognizable faces of the Natural Products Association will be leaving association work in favor of the Food and Drug Administration, Drug Store News learned Wednesday.

February 1, 2011

As soon as members of Congress took their seats last month, the new Republican majority announced it would make good on its pledge to repeal the Patient Protection and Affordable Care Act. The effort largely is symbolic and unlikely to succeed, so at least one portion of the healthcare-reform law will likely remain in effect, namely the abbreviated approval pathway for follow-on biologics, also known as the Biologics Price Competition and Innovation Act.


February 1, 2011

Thanks to technological innovations within mascara, the category has driven sales of eye makeup, and looking forward, mascara formulas that are infused with eyelash-enhancing treatments and packaging that offers greater customization not only will volumize lashes but also sales at retail.


February 1, 2011

The Food and Drug Administration has turned down an application for an anti-obesity drug.

February 1, 2011

The Food and Drug Administration has approved a Novartis vaccine for preventing meningococcal disease in children, the Swiss drug maker said.

February 1, 2011

Optivia Biotechnology on Tuesday announced that the company and the Food and Drug Administration have signed a collaboration agreement to assess the effect of dietary supplements on key drug transporters.

February 1, 2011

SUPPLIER NEWS — The Food and Drug Administration has approved a generic drug made by Watson Pharmaceuticals for cancer-related breakthrough pain, Watson said. The drug is a generic version of Cephalon’s Fentora, which had sales of around $179 million during the 12-month period ended in November 2010, according to IMS Health.


February 1, 2011

Years 2009 and 2010 were up and down for the generic drug industry and its main trade group, the Generic Pharmaceutical Association. On one hand, there were the departures of president and CEO Kathleen Jaeger and member company Teva Pharmaceutical Industries.

January 31, 2011

Mylan has announced its intention to market a version of a painkiller made by Endo Pharmaceuticals and partner company Teikoku Seiyaku ahead of patent expiration.

January 31, 2011

Transcept announced Monday that the Food and Drug Administration has classified the drug maker's insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.

January 28, 2011

Though Schering-Plough’s — now Merck’s — Claritin and Johnson & Johnson’s Zyrtec product lines have dominated the over-the-counter antihistamine market, the big share of the prescription antihistamine market held by Sanofi-Aventis’ Allegra (fexofenadine hydrochloride) could give it a battering ram to bust in as well, thanks to the big break Sanofi got in the form of a Food and Drug Administration approval of an OTC switch for the drug.

January 28, 2011

The Food and Drug Administration has approved a generic hypertension treatment made by Mylan.

January 27, 2011

The Food and Drug Administration has accepted a regulatory approval application for a pain drug that it previously had declined to approve.

January 27, 2011

The safety of silicone breast implants has long been a subject of controversy, but a review by the Food and Drug Administration indicated another possible health risk.

January 27, 2011

The Food and Drug Administration declined to approve a regulatory approval application from British drug maker GlaxoSmithKline concerning a cancer drug, GSK said Wednesday.

January 26, 2011

Watson Pharmaceuticals is seeking regulatory approval for a generic drug for high cholesterol.

January 25, 2011

Eisai will not seek regulatory approval for a drug to treat severe sepsis after getting lackluster results from a late-stage clinical trial, the drug maker said Tuesday.

January 25, 2011

Sanofi-Aventis and its U.S. consumer healthcare division Chattem on Tuesday afternoon announced the Food and Drug Administration has approved the Allegra (fexofenadine HCl) family of allergy medication products for over-the-counter use in adults and children 2 years of age and older.

January 25, 2011

Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

January 24, 2011

The Food and Drug Administration has accepted a regulatory filing from Optimer Pharmaceuticals for a drug to treat bacterial infections.

January 24, 2011

The Food and Drug Administration has approved a treatment for gastroesphageal reflux disease made by a subsidiary of Mylan, the generic drug maker said Monday.