February 11, 2011

The Food and Drug Administration announced Friday the approval of Waltham, Mass.-based Thermo Fisher’s QMS Everolimus Immunoassay, a test that monitors the blood for levels of Novartis’ drug Zortress (everolimus).

February 11, 2011

Genentech, a subsidiary of Roche, reported that its eye drug helped improve vision in patients suffering from a complication caused by diabetes.

February 11, 2011

The Food and Drug Administration has approved a drug for preventing preterm births.

February 11, 2011

The Food and Drug Administration has approved a painkiller delivered through a skin patch made by Mallinckrodt, the generic drug maker said Friday.

February 11, 2011

Teva earlier this week announced it had submitted a request to the Food and Drug Administration to allow for the sale of the emergency contraceptive Plan B One-Step to women under the age of 17 years without a prescription, according to published reports.

February 10, 2011

Actavis has received approval from the Food and Drug Administration to market a generic version of a popular gastroesophageal reflux disease treatment.

February 10, 2011

This year’s upcoming $29 billion wave of margin-friendly generic pharmaceuticals will be as big a growth catalyst for supermarket pharmacies as it will be for their pureplay drug store cousins, Credit Suisse research analyst Ed Kelly stated in a note published Thursday.

February 10, 2011

The Food and Drug Administration will propose an amendment to the over-the-counter laxative monograph that sodium phosphate salts are not generally recognized as safe for bowel cleansing.

February 8, 2011

The National Advertising Division of the Council of Better Business Bureaus on Tuesday referred advertising claims made by Iceberg Labs for its Immune Shield dietary supplement to the Federal Trade Commission and Food and Drug Administration for further review.

February 8, 2011

The Food and Drug Administration has given expedited review to a drug for preventing hemodialysis failure in patients with end-stage kidney disease.

February 7, 2011

The Food and Drug Administration has approved a generic cancer drug from Hospira.

February 4, 2011

The Food and Drug Administration has approved a generic weight-loss drug made by Elite Pharmaceuticals.

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.