Content about Food and Drug Administration

October 24, 2013

The Food and Drug Administration has approved a new formulation of a drug made by Genentech for rheumatoid arthritis that can be injected into the skin.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a new formulation of a drug made by Genentech for rheumatoid arthritis that can be injected into the skin.

Genentech announced the approval of a subcutaneous formulation of Actemra (tocilizumab) in adults for adults with moderate RA who have not found sufficient relief by taking such disease-modifying antirheumatic drugs as methotrexate. Like the intravenous formulation of Actemra, the new version can be used alone or with drugs like methotrexate.

October 24, 2013

The Food and Drug Administration has granted breakthrough therapy designation to an experimental drug made by Merck for hepatitis C, the drug maker said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has granted breakthrough therapy designation to an experimental drug made by Merck for hepatitis C, the drug maker said.

October 23, 2013

The Food and Drug Administration plans to complete its phase out of inhalers that contain ozone-depleting chlorofluorocarbons by the end of the year, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration plans to complete its phase out of inhalers that contain ozone-depleting chlorofluorocarbons by the end of the year, the agency said Wednesday.

October 22, 2013

A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.

LAKE FOREST, Ill. — A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.

October 22, 2013

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

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

The agency approved Famy's levonorgestrel and ethinyl estradiol tablets in the 0.02-mg/0.1-mg strengths.

The drug is a generic version of Aviane-28, made by Teva Women's Health, a division of Israeli drug maker Teva Pharmaceutical Industries that previously went under the name Duramed.

 

October 22, 2013

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

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

Jubilant, based in India, announced the approval of generic bupropion hydrochloride extended-release tablets in the 100-mg, 150-mg and 200-mg strengths, and another bupropion hydrochloride extended-release tablet product in the 150-mg strength.

The first product is a generic version of GlaxoSmithKline's antidepressant Wellbutrin SR, while the second is a version of GSK's anti-smoking drug Zyban.

October 22, 2013

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

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

The FDA approved a generic version of Mission Pharmacal's Tindamax (tinidazole) made by Unique Pharmaceuticals. The drug is a tablet in the 250-mg and 500-mg strengths.

Tindamax is used to treat bacterial vaginosis, trichomoniasis and giardiasis. The drug has annual sales of about $16.2 million, according to IMS Health.

 

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.

SILVER SPRING, Md. — 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.

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

The drug maker announced the approval of Zorvolex (diclofenac) capsules for mild to moderate acute pain in adults. The drug is a non-steroidal anti-inflammatory drug, or NSAID, belonging to the same class as the common analgesic drug ibuprofen. Zorvolex was approved at dosage strengths 20% lower than currently available diclofenac products, the company said.

October 21, 2013

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

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

The agency announced the approval of Opsumit (macitentan) for adults with PAH, a chronic, progressive and debilitating disease caused by high blood pressure in the arteries that connect the heart to the lungs that can lead to death or the need for lung transplantation.

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.

SILVER SPRING, Md. — 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 Monday.

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.

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

The drug maker — the U.S. subsidiary of Germany's Merck Serono, so-called to distinguish it from U.S.-based Merck & Co. — announced the approval of Gonal-f RFF Redi-ject (follitropin alfa), a disposable pre-filled injector pen intended for injection under the skin of a liquid formulation of Gonal-f RFF. The pens will be available in the United States in December.

October 18, 2013

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

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

The drug maker said Friday that the FDA had approved Cimzia (certolizumab pegol) for adults with active ankylosing spondylitis, though it declined to approve the drug for axial spondyloarthritis, or axSpA. UCB said it was working with the agency to determine how to get the drug approved for axSpA.

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.

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.

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

Novo Nordisk announced the approval of Novoeight (turoctocog alfa), a recombinant coagulation factor VIII, for adults and children with hemophilia, a disease caused by factor VIII deficiency that results in uncontrollable bleeding.

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.

NEW YORK — 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.

DUBLIN — 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.

The generic drug maker said it had filed a regulatory approval application with the Food and Drug Administration for buprenorphine hydrochloride and naloxone hydrochloride sublingual film in the 2-mg/0.5-mg and 8-mg/2-mg strengths. The drug is a generic version of Reckitt Benckiser's Suboxone.

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.

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

The Israeli drug maker announced the approval of the antibiotic drug tobramycin inhalation solution, a generic version of Novartis' Tobi.

Tobi has sales of about $350 million during the 12-month period that ended in June, according to IMS Health.

 

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.

NEW YORK — 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.

EWING, N.J. — 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.

NEW BRUNSWICK, N.J. — 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.

PARIS — 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. 

Nasacort is the first and only nasal corticosteroid to be available without a prescription and will be marketed by Sanofi's consumer healthcare division, Chattem.

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.

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.

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.

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.

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.

Last month, the company — which specializes in making generic injectable drugs — announced that European Union regulators had approved the continent’s first biosimilar monoclonal antibody.