Branded

PHILADELPHIA — The Food and Drug Administration has approved a new use for a Shire drug to treat attention deficit hyperactivity disorder, Shire said Monday.

The FDA approved Intuniv (guanfacine) as an add-on therapy for children and adolescents already taking stimulants to treat ADHD, also known as an adjunctive therapy.

The approval was based on a nine-week placebo-controlled study of the drug in which children and adolescents received it in combination with a stimulant.

WASHINGTON — More than 400 drugs are in late-stage clinical development or awaiting Food and Drug Administration approval as treatments for rare diseases, according to a report by the drug industry lobby.

KARMIEL, Israel — The Food and Drug Administration has declined to approve a biologic treatment for a rare genetic disorder by Israeli drug maker Protalix Biotherapeutics, Protalix said Friday.

The company said the FDA issued a complete response letter for its application for taliglucerase alfa, a treatment for Gaucher disease. The FDA issues a CRL when it has finished reviewing a regulatory application, but questions remain that preclude final approval.

OSAKA, Japan — Drug maker Takeda has filed for regulatory approval of a drug to treat hypertension, the company said Wednesday.

Takeda announced that it had submitted an application with the Food and Drug Administration for the fixed-dose drug azilsartan medoxomil and chlorthalidone. Azilsartan medoxomil is an angiotensin II receptor blocker, or ARB, that lowers blood pressure by blocking the angiotensin II hormone.

WOODCLIFF LAKE, N.J. — Generic drug maker Par Pharmaceutical Cos. had sales of $227 million during fourth quarter 2010 and $1 billion for the year as a whole, according to an earnings statement Thursday.

Profits were $17.5 million for the quarter and $92.7 million for the year, compared with $10.7 million in fourth quarter 2009 and $76.9 million for 2009 as a whole.

PRINCETON, N.J. — Novo Nordisk has filed for approval of a treatment for a rare genetic bleeding disorder, the Danish drug maker said Wednesday.

The company submitted to the Food and Drug Administration its application for recombinant factor XIII compound, for congenital factor XIII deficiency. Current treatments for FXIII deficiency use products derived from human blood plasma, which carries the risk of contamination.

ST. PAUL, Minn. — Use of amphetamines could increase the risk of Parkinson’s disease, according to a new study.

PRINCETON, N.J., and WILMINGTON, Del. — The makers behind a popular Type 2 diabetes treatment have included data from two clinical studies in an update to the drug's prescribing information.

Bristol-Myers Squibb and AstraZeneca said the Food and Drug Administration approved the labeling update for Onglyza (saxagliptin), which now includes efficacy and safety information about the drug's effects on patients with renal impairment or end-stage renal disease.