February 23, 2011

Biotab Nutraceuticals on Tuesday initiated a voluntary recall of two lots of Extenze nutritional supplement tablets.

February 23, 2011

Drug maker Forest Labs plans to acquire the developer of a recently approved antidepressant.

February 23, 2011

The makers behind a popular Type 2 diabetes treatment have included data from two clinical studies in an update to the drug's prescribing information.

February 22, 2011

Generic drug maker Hi-Tech Pharmacal has received Food and Drug Administration approval for its version of a drug used to treat neurological disorders, the company said Tuesday.

February 22, 2011

Generic drug maker Perrigo has filed for approval of a drug to treat psoriasis with the Food and Drug Administration.

February 22, 2011

Prasco Labs will distribute an authorized generic version of an ulcerative colitis treatment made by Shire in the event that any other company steps forward to file an abbreviated new drug application for the drug.

February 18, 2011

Though efforts to repeal the Patient Protection and Affordable Care Act via the court system remain under way — with recent victories for opponents in Virginia and Florida — the attempt to repeal the healthcare-reform bill in Congress failed, thus leaving the bill and, most importantly, the regulatory approval pathway for follow-on biologics intact.


February 18, 2011

A whole slew of drugs will lose patent protection this year, opening up opportunities for generic drug makers to market their own versions. Most notable among these is Pfizer’s cholesterol-
lowering drug Lipitor (atorvastatin), the world’s top-selling drug, with U.S. sales of $7 billion during the 12 months ended September 2010, according to IMS Health.


February 18, 2011

The Food and Drug Administration has approved a treatment for a rare bleeding disorder.

February 18, 2011

An asthma drug widely available as a generic should not be used for preventing or treating preterm labor in pregnant women, the Food and Drug Administration warned.

February 18, 2011

A generic drug maker received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment.

February 18, 2011

Generic drug usage already has been on the rise year after year, with no sign of slowing down. As Jody Fisher, VP marketing for healthcare analytics at market research firm SDI, has told Drug Store News, generics accounted for more than 70% of products dispensed at retail pharmacies and are set to increase further this year.


February 18, 2011

SUPPLIER NEWS — Drug maker Valeant Pharmaceuticals International has acquired U.S. and Canadian rights to certain formulations of a GlaxoSmithKline drug used to treat cold sores. Valeant acquired the rights to nonophthalmic topical formulations of Zovirax (acyclovir) from GSK for $300 million through its Canadian subsidiary, Biovail Labs.



February 17, 2011

The Food and Drug Administration has seized supplies of a drug used to treat ear infections, under a program the agency started to remove unapproved drugs from the market.

February 17, 2011

The Food and Drug Administration has approved a psychiatric drug for treating bipolar disorder when used in combination with one of two other drugs.

February 17, 2011

Savient Pharmaceuticals announced changes to its management team as it gears up for the commercial launch of its chronic gout treatment.

February 15, 2011

Mylan has launched a generic drug for fungal infections, the company said Tuesday.

February 14, 2011

GlaxoSmithKline has changed prescribing information on the labeling for one of its Type 2 diabetes drugs to reflect new restrictions on the drug’s use, the drug maker said.

February 14, 2011

The Food and Drug Administration has accepted for review an application for a pain medication designed to thwart drug abusers.

February 14, 2011

Gilead Sciences has refiled an approval application with the Food and Drug Administration for an HIV drug, the drug maker said.

February 11, 2011

The Food and Drug Administration has approved Hi-Tech Pharmacal’s generic version of a drug for eye infections.

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.