October 22, 2013

The Food and Drug Administration has approved a generic contraceptive drug made by Famy Care, agency records show.

October 22, 2013

The Food and Drug Administration has approved drugs for depression and smoking cessation made by Jubilant Life Sciences, the company said.

October 22, 2013

The Food and Drug Administration has approved a new generic drug for treating bacterial and protozoan infections, according to the agency.

October 22, 2013

The Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, on Monday sought a permanent injunction against the dietary supplement manufacturer James G. Cole; its president, James Cole; and its general manager, Julie Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug and Cosmetic Act.

October 21, 2013

The Food and Drug Administration has approved a pain drug made by Iroko Pharmaceuticals, Iroko said.

October 21, 2013

The Food and Drug Administration has approved a new drug made by Actelion Pharmaceuticals for treating pulmonary arterial hypertension.

October 21, 2013

The Food and Drug Administration is offering more than $14 million in grants for the development of products for patients with rare diseases, the agency said.

October 18, 2013

The Food and Drug Administration has approved a pre-filled injector pen made by EMD Serono for infertile women, the company said Friday.

October 18, 2013

The Food and Drug Administration has approved a drug made by UCB for treating a form of arthritis.

October 18, 2013

Chattem recently announced that the Food and Drug Administration approved Nasacort Allergy 24HR nasal spray (triamcinolone intranasal) as an over-the-counter treatment for seasonal and year-round nasal allergies. And that means by spring 2014, there will be another allergy powerhouse alongside Allegra, Claritin and Zyrtec.

October 17, 2013

The Food and Drug Administration has approved a new drug made by Novo Nordisk for treating hemophilia A, the Danish drug maker said.

October 17, 2013

As knock-off versions of biotech drugs get closer to reality in the United States, one issue that has emerged has centered on what to call them.

October 15, 2013

Actavis is hoping to become the first to market a generic version of a drug used to treat patients who have become dependent on opioid drugs, triggering a lawsuit from the branded drug's manufacturer.

October 15, 2013

The Food and Drug Administration has approved a new generic drug from Teva Pharmaceutical Industries for treating eye infections, the company said.

October 14, 2013

The governor of California has vetoed a bill that critics said would have limited patients' access to knock-off versions of biotech drugs.

October 14, 2013

The Food and Drug Administration has approved a new drug made by Antares Pharma for treating rheumatoid arthritis and psoriasis, the drug maker said Monday.

October 14, 2013

Johnson & Johnson on Monday announced that Mark McClellan, senior fellow in economic studies and director of the Initiative on Value and Innovation in Health Care at the Brookings Institution, will join the company's board of directors on Oct. 15. McClellan will serve on the regulatory, compliance and government affairs committee, as well as the science, technology and sustainability committee.

October 14, 2013

Allergy sufferers will have a new treatment option available to them by the spring allergy season. Sanofi on Friday announced that the Food and Drug Administration approved Nasacort Allergy 24HR nasal spray (triamcinolone intranasal) as an over-the-counter treatment for seasonal and year-round nasal allergies in adults and children 2 years of age and older.

October 11, 2013

A new law in Maine will allow the importation of drugs from abroad through mail-order from some pharmacies, formalizing a practice that has existed in many parts of the country for several years, and marking the first time a state government has, by law, gone against Food and Drug Administration regulations that bar importation of drugs.

Bloomberg columnist Megan McArdle said Maine was "going rogue" on drug importation, and that pretty much sums it up. The state, which has long had a close relationship with Canada — its governor, Paul LePage, is of French-Canadian descent and spoke Quebecois French as his first language — is openly defying federal law. And because federal law ultimately trumps state law, it's likely the federal government will crack down at some point.

October 10, 2013

Sales of Hyland’s oral analgesic products are up 23.5% to $15.4 million for the 52 weeks ended Aug. 11 across U.S. multi-outlets, according to IRI. Overall sales trends across the category are down by 1.7%, which suggests that what Hyland’s is doing is right — its products are safe, they work and they aren’t formulated with benzocaine.

October 10, 2013

When it comes to laws and regulations, what happens in Europe stays in Europe generally, and doesn’t have much bearing on the United States. But a recent win in Europe for U.S. drug maker Hospira could have some implications for the United States as well.

October 10, 2013

One of the Food and Drug Administration's top regulators is not retiring, contrary to rumors reported in news media Thursday.

October 10, 2013

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

October 10, 2013

While the boom in generic drugs now looks set to wane, another segment of the pharmaceutical industry is rapidly rising and presenting new growth opportunities for pharmacy retailers: specialty drugs.