Content about Anti-diabetic drugs

NEW DELHI — The Food and Drug Administration has approved a diabetes drug made by Lupin Pharmaceuticals, according to published reports.

The FDA approved Lupin’s metformin hydrochloride extended-release tablets, a generic version of Andrx Labs’ Fortamet.

Fortamet had sales of $83 million in 2010, according to IMS Health.

CLEVELAND — A drug used to treat diabetes also may prevent it, according to a new study published in the journal Experimental Biology and Medicine.

Researchers at Case Western Reserve University took specially bred obese, prediabetic rats and gave them either Merck’s Januvia (sitagliptin), placebo or glyburide, an older diabetes drug. Both of the diabetes drugs lowered blood-glucose levels after the rats had eaten, but only Junuvia raised the total output of insulin by the pancreas while lowering levels of glucagon.

SAN DIEGO — Amylin Pharmaceuticals and Takeda Pharmaceutical have suspended a mid-stage trial of an obesity drug over safety concerns, the two said Wednesday.

The drug makers stopped the phase-2 trial of a combination of pramlintide and metreleptin due to problems that arose in two patients related to metreleptin. Amylin said the decision to suspend the trial did not affect its investigations of metreleptin as a treatment of diabetes and hypertriglyceridemia in patients with lipodystrophy.

DANBURY, Conn. — A drug maker focused on development and commercialization of diabetes treatments unveiled its accelerating clinical development plans of two drug candidates.

Biodel said BIOD-105 and BIOD-107, known as ultra rapid-acting insulins, are designed to result in more rapid insulin action, compared with currently marketed mealtime insulin analogs.

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.

BAGSVÆRD, Denmark — A collection of relatively new products helped drive up sales and profits at Novo Nordisk, the Danish drug maker said Wednesday. 

Sales increased by 22% in the North American markets when measured in local currencies, and by 29% when measured in Danish kroner, the company said. Operating profits were $3.5 billion, a 16% increase over 2009.

CRAWLEY, England — An insulin pen for children made by Novo Nordisk has won a design award, the company said Wednesday.

The Danish drug maker won the 2010 Good Design Award from the Chicago Athenaeum Museum of Architecture and Design and the European Centre for Architecture, Art, Design and Urban Studies for its NovoPen Echo, used to treat Type 1 diabetes. The annual award, which the two organizations have given since 1950, are the oldest and among the most coveted for design and innovation, Novo Nordisk said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a drug to treat Type 2 diabetes made by Merck, the drug maker said Tuesday.

Merck announced the acceptance of its application for extended-release Janumet, which combines in a single pill the active ingredient sitagliptin with extended-release metformin, a drug commonly prescribed for Type 2 diabetes.

NEW YORK — This past year saw a lower-than-usual number of new drugs approved by the Food and Drug Administration, due in part to delays at the agency, according to published reports.

The Wall Street Journal reported that 21 new drugs were approved through the year, compared with 25 in 2009 and 24 in 2008. The lag came in part due to stricter safety regulations, the newspaper reported.

SAN DIEGO — Drug maker Amylin Pharmaceuticals has submitted the first of a series of sections of a regulatory approval application for a biotech drug to treat patients with a rare lipid disorder.

Supplier News — Fera Pharmaceuticals has recently launched two new topical ointments. The New York-based company has developed Ilotycin (erythromycin) and Garamycin (gentamicin) ophthalmic ointments, both for the treatment of bacterial infections of the eye. “Our goal is simple: to keep more quality healthcare choices alive for the people who need them,” company co-founder Frank DellaFera said.