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DUBLIN — 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.

Shire said the FDA’s Pulmonary-Allergy Drugs Advisory Committee recommended approval of Firazyr (icatibant) for treating acute hereditary angioedema attacks in adults. The committee also voted 11-1 to recommend approval of self-administration of the drug by patients.

HAE is a genetic and potentially fatal immune system disorder that causes swelling of the face and airways and result in airway blockage.

WILMINGTON, Del. — AstraZeneca announced that it is selling its Astra Tech business to a professional dental products company in a cash transaction valued at about $1.8 billion.

Dentsply will acquire Mölndal, Sweden-based Astra Tech, which focuses on dental and healthcare products, services and support. In 2010, Astra Tech recorded worldwide revenue of $535 million.

AstraZeneca noted that the transaction is anticipated to be completed during the second half of 2011.

CHADDS FORD, Pa. — Endo Pharmaceuticals has acquired a provider of devices and therapies for male and female pelvic health.

Endo said its acquisition of American Medical Systems has boosted the drug maker's devices and services business segment, and the combination of AMS with Endo's existing platform will provide additional cost-effective solutions across the entire urology spectrum.

The company announced its definitive agreement to acquire AMS in a cash transaction valued for approximately $2.9 billion.

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

Abbott announced Monday the approval of a 45-mg, six-month formulation of Lupron Depot (leuprolide acetate) for advanced prostate cancer. Previous formulations have allowed patients to receive the drug every month or every three or four months.

TITUSVILLE, N.J. — Johnson & Johnson is recalling 40,000 bottles of a drug used to treat schizophrenia due to consumer reports of the drug having a strange odor, the company said Friday.

J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals announced the voluntary recall of one lot of Risperdal (risperidone) tablets in the 3-mg strength and a lot of authorized generic risperidone tablets in the 2-mg strength made by Patriot Pharmaceuticals, also a J&J subsidiary.

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.


SILVER SPRING, Md. — The Food and Drug Administration on Thursday informed the public that continued use of a Type 2 diabetes treatment made by Takeda Pharmaceuticals for more than one year may be associated with an increased risk of bladder cancer.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for preventing organ rejection in kidney transplant patients, the agency said Wednesday.

The FDA approved Bristol-Myers Squibb’s Nulojix (belatacept), for preventing acute rejection in adult patients. The drug is approved for use with other immune system-suppressing drugs, specifically Novartis’ Simulect (basiliximab), Genentech’s CellCept (mycophenolate mofetil) and corticosteroids.

INDIANAPOLIS — A new oral medication for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim has become available in pharmacies, the companies said Wednesday.

Lilly and BI announced the availability of Tradjenta (linagliptin) in chain and independent pharmacies around the country.

ABBOTT PARK, Ill. — The Food and Drug Administration has approved a new dosage of a drug made by Abbott for treating cystic fibrosis in infants, the drug maker said Tuesday.

Abbott announced the approval of an infant-specific dose of Creon (pancrelipase) delayed-released capsules to treat exocrine pancreatic insufficiency due to cystic fibrosis.

RESEARCH TRIANGLE PARK, N.C. — The Food and Drug Administration has approved a new drug for epilepsy made by GlaxoSmithKline and Valeant Pharmaceuticals International, the drug makers said Monday.

The FDA approved Potiga (ezogabine) tablets for the treatment of partial-onset seizures in patients ages 18 years and older.

SILVER SPRING, Md. — The Food and Drug Administration has approved changes to the labels of several drugs made by Merck, the agency said Friday.

Merck’s Label Standardization Project includes the revision of 34 container labels for 16 drugs, all orally administered pills. These include the cardiovascular drugs Cozaar (losartan) and Hyzaar (losartan and hydrochlorothiazide), the diabetes drugs Januvia (sitagliptin) and Janumet (sitagliptin and metformin), the allergy and asthma drug Singulair (montelukast), the HIV drug Isentress (raltegravir) and others.