July 5, 2011

Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

July 5, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said Friday.

June 30, 2011

A group of physicians is urging the Food and Drug Administration not to approve a drug made by Gilead Sciences for the prevention of HIV infection.

June 29, 2011

Important safety information often is missing from drug labels, while some pharmacies don’t include medication guides required by the federal government, according to a new investigation by Consumer Reports.

June 29, 2011

Legislation has been introduced that would require stricter labeling requirements of cosmetics and personal care products and give the Food and Drug Administration recall authority for products that are misbranded, adulterated or otherwise fail to meet safety standards.

June 28, 2011

Generic drug maker Hi-Tech Pharmacal said that it has acquired marketing and distribution rights to pain treatments made by Atley Pharmaceuticals.

June 28, 2011

The Obama administration recently called on the public for ideas to streamline federal regulations. In response, the National Association of Chain Drug Stores has sent its suggestion to the Food and Drug Administration.

June 28, 2011

A new multimedia public service campaign that is designed to help families prevent food poisoning in the home has made its debut.

June 27, 2011

The Food and Drug Administration has accepted a regulatory approval application for a drug designed to prevent premature birth in pregnant women.

June 24, 2011

The Food and Drug Administration has accepted a resubmission by Endo Pharmaceuticals of a regulatory application for an opioid pain drug designed to thwart abuse, Endo said.

June 24, 2011

A Food and Drug Administration expert panel has recommended approval of a drug made by Shire for a rare immune system disorder, the drug maker said.

June 24, 2011

The Food and Drug Administration has declined to approve an investigative painkiller made by Pfizer, the drug maker said Friday.

June 22, 2011

Generic drug maker Dr. Reddy’s Labs has launched its version of a popular antibiotic.

June 22, 2011

The Food and Drug Administration has approved a medication designed to treat acute and chronic moderate to severe pain, where the use of an opioid analgesic is suitable.

June 22, 2011

ProStrakan has received approval from the Food and Drug Administration to market an ointment designed to treat moderate to severe pain associated with chronic anal fissures.

June 21, 2011

The Food and Drug Administration Tuesday approved the first generic versions of an antibiotic designed to treat certain infections in people ages 18 years and older.

June 21, 2011

The Department of Health and Human Services on Tuesday morning unveiled the nine graphic health warnings mandated by the Food and Drug Administration to appear on every pack of cigarettes sold in the United States and in every cigarette advertisement.

June 21, 2011

Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

June 20, 2011

The Food and Drug Administration has approved a new formulation of an injectable drug made by Abbott for prostate cancer.

June 20, 2011

A panel of Food and Drug Administration experts has recommended approval of an investigational biotech drug made by Regeneron Pharmaceuticals for eye diseases.

June 20, 2011

Just after the approval of their new treatment for Type 2 diabetes, Eli Lilly and Boehringer Ingelheim plan to present data in more than two dozen presentations at the American Diabetes Association Scientific Sessions starting this week.

June 20, 2011

Mylan has scored a victory in its efforts to make a generic version of a Teva drug for multiple sclerosis.

June 20, 2011

Last month, the Food and Drug Administration approved Tradjenta (linagliptin), an oral Type 2 diabetes drug made by German drug maker Boehringer Ingelheim and Indianapolis-based Eli Lilly. The drug belongs to the class known as dipeptidyl peptidase-4 inhibitors, which also includes Merck’s Januvia (sitagliptin). With diabetes affecting some 26 million Americans and growing rapidly, Drug Store News spoke with Wa’el Hashad, BI’s VP cardiovascular and metabolic disorders marketing, about what the approval of Tradjenta means for the diabetes market.


June 20, 2011

A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment.