Content about Food and Drug Administration

The year 2012 is coming to an end, and it's been a big year for generic drugs. It's the year that the most lucrative drug of all time became commoditized. It's the year that Watson bought Actavis for $5.6 billion. And it's the year the FDA released draft guidance for biosimilars regulations. All of these events speak to some of the most important trends in the world of generics — trends that are often interrelated.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a drug for a type of lung cancer.

Roche subsidiary Genentech and the U.S. subsidiary of Japan's Astellas Pharma announced the approval of Tarceva (erlotinib) for advanced non-small cell lung cancer whose tumors have mutations that activate the epidermal growth factor receptor. The FDA also approved a test to detect the mutation.

The drug was already approved for advanced NSCLC that did not exhibit the mutation.

PITTSBURGH — The Food and Drug Administration has approved a generic migraine drug made by Mylan, the company said Wednesday.

Mylan announced the approval of zolmitriptan tablets in the 2.5 mg and 5 mg strengths. The drug maker plans to launch the product immediately.

The drug is a generic version of IPR Pharmaceuticals' Zomig and is used for the acute treatment of migraine in adults. Various versions of the drug had sales of $152.8 million during the 12-month period that ended in March, according to IMS Health.

PARSIPPANY, N.J. — The Food and Drug Administration will review an experimental contraceptive patch made by Actavis, the drug maker said Tuesday.

Actavis said the FDA accepted for review its application for norethindrone transdermal delivery system. The patch, which does not yet have a brand name, is designed to provide continuous delivery of norethindrone during a once-weekly, seven-day dosing regimen.

NEW YORK — The Food and Drug Administration's temporary stay pending its appeal of a district court decision ordering all levonorgestrel-based emergency contraceptives be available without a prescription and without any age restrictions was extended through May 28 by the U.S. Court of Appeals for the Second Circuit on Monday. 

The Second Circuit will entertain the appeal on that day. 

EAST HANOVER, N.J. — The Food and Drug Administration has approved a biotech drug made by Novartis for treating a form of arthritis that affects children, the Swiss drug maker said Friday.

The November 2011 expiration of Pfizer's patent on the cholesterol drug Lipitor and Ranbaxy Labs' release of the generic version received significant play in the media, particularly due to the theretofore status of Lipitor (atorvastatin calcium) as the drug with the highest sales in the country, $7.7 billion in the United States, according to healthcare analytics firm IMS Health.

WASHINGTON — One of the difficulties that federal regulators ran into during the nationwide scandal surrounding the New England Compounding Center — the Massachusetts-based pharmacy blamed for a nationwide fungal meningitis epidemic that has sickened hundreds and killed dozens — was the issue of when such pharmacies cross the line from compounding to manufacturing.

WHITEHOUSE STATION, N.J. — Drug maker Merck is seeking regulatory approval for an experimental tablet placed under the tongue that could be used to treat ragweed allergies.

Merck said the Food and Drug Administration accepted a regulatory application for its ragweed pollen sublingual allergy immunotherapy tablet. Ragweed, also known as Ambrosia artemisiifolia, is a major cause of seasonal allergies in the United States. Merck also submitted an application for a similar drug, for Timothy grass pollen allergies, in March.

LONDON — The global market for biosimilars will be worth nearly $2.5 billion this year, according to a new study.

The study, by British market research firm Visiongain, forecast that the $2.445 billion market size marked more than 20% of growth from 2012 and would account for about 2% of the overall market for biologics. The market is expected to grow rapidly through 2023 as biosimilars hit the market in the United States and European Union.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a new drug made by Merck for treating high cholesterol, the drug maker said.

Merck announced the approval of Liptruzet (ezetimibe and atorvastatin). The drug combines two preexisting cholesterol drugs: ezetimibe, which Merck markets under the brand name Zetia, and atorvastatin, which Pfizer markets under the name Lipitor. Both drugs are available as generics, but because Liptruzet is a novel combination of them, it required FDA approval as a new drug.

WASHINGTON — The Food and Drug Administration may soon find itself in another Plan-B-generated quandary — the complications around granting a three-year marketing exclusivity for a medicine that is both prescription-only and over-the-counter, according to an FDA Law Blog posted Sunday by Hyman, Phelps & McNamara.