Amneal to manufacture generic Furadantin
BRIDGEWATER, N.J. — A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment.
Amneal Pharmaceuticals said that its nitrofurantoin oral suspension in the 25-mg/5-mL strength is the first-to-market, AB-rated, generic version of Furadantin, which is made by Shionogi Pharma.
Amneal will sell its generic in 8-oz./230-mL size bottles, the company said.
Annual U.S. sales of nitrofurantoin oral suspension totaled $40 million for the year ended in January, according to IMS Health data.
Patients, gov’t benefit from generic SSRI, SNRI adherence
The $290 billion that poor medication adherence costs the U.S. economy every year cuts across every imaginable disease state, but one in which it can be particularly problematic is mental health.
According to pharmacy benefit manager Express Scripts, depression accounts for more than $83 billion in medical costs every year, making it a major cause of disability. According to the National Institute of Mental Health, major depressive disorder affects 6.7% of adults in the United States per year, while 11.2% of adolescents experience the disorder at some point between the ages of 13 and 18 years.
One study conducted by Express Scripts and published in the Journal of Managed Care Pharmacy found that patients with depression who started therapy with generic drugs were as likely to remain adherent as those who started on branded drugs. The study — which analyzed data on antidepressant usage from more than 16,000 patient records in Express Scripts’ MarketScan database — showed that patients who started with generic versions of selective serotonin reuptake inhibitors and selective norepinephrine reuptake inhibitors had a therapy-discontinuation rate of 44.2%, compared with 46.8% among those taking branded SSRIs and SNRIs. But at the same time, drug costs for those taking generics were almost 50% lower, and total healthcare costs were approximately 20% lower, costing an average of $3,660 for patients starting on a generic and $4,587 for those starting on a branded drug.
Depression as a side effect of medications can affect adherence as well, such as with interferons used to treat hepatitis C. According to a 3,607-patient study conducted by PBM Medco Health Solutions in April, adherence among hepatitis C patients may improve when they take antidepressants in addition to their interferons. “A common side effect of interferon use is depression, but little research has been done looking at the impact of treating depression on a patient’s adherence with their hepatitis C medications,” Medco Advanced Clinical Science and Research Group director of clinical innovation Mary Cassler said.
The study found that 40% of hepatitis C patients taking interferons — which include Genentech’s Pegasys (peginterferon alfa-2a) and Merck’s PegIntron (peginterferon alfa-2b) — were not adherent, which could put them at risk of the disease progressing, but those who were taking antidepressants as well as interferons had the highest rates of adherence, with 68.5% taking their drugs properly.
ReportersNotebook — Chain Pharmacy, 5/30/11
SUPPLIER NEWS — The FDA has approved a new treatment for Type 2 diabetes, the agency said. The FDA announced the approval of Tradjenta (linagliptin) made by Indianapolis-based Eli Lilly and German drug maker Boehringer Ingelheim.
Alza Corp. is attempting to block Impax Labs from developing a generic version of Alza’s attention deficit hyperactivity disorder treatment. Impax confirmed that Alza filed a patent infringement suit in the U.S. District Court for the District of Delaware against the generic drug maker in connection with Concerta (methylphenidate hydrochloride) extended-release tablets in the 18-mg, 27-mg and 36-mg strengths, which are designed to treat ADHD in children ages 6 years and older, adolescents and adults up to the age of 65 years.
A generic drug maker has launched its version of a pain medication made by Endo Pharmaceuticals. Mylan and its subsidiary Mylan Pharmaceuticals launched oxycodone and aspirin tablets USP in the 4.8355-mg/325-mg strength, based on an agreement with licensing partner Coastal Pharmaceuticals. The drug, designed to treat moderate to severe pain, is a generic version of Percodan.
The Food and Drug Administration has approved a drug made by Novartis as the first treatment for advanced pancreatic neuroendocrine tumors, Novartis said in May. Novartis announced the approval of Afinitor (everolimus), saying it marked the first approval of a drug for advanced pancreatic NET in nearly 30 years. The drug already is approved for treating cancers of the kidney and brain.
Greenstone has introduced an authorized generic treatment for breast cancer, the generics subsidiary of Pfizer said. The company announced the launch of exemestane tablets, an authorized generic version of Pfizer’s Aromasin. Aromasin is used to treat early breast cancer in menopausal women who already have taken the drug tamoxifen for two to three years, as well as breast cancer in women whose disease has worsened while taking tamoxifen, which is widely available as a generic. Authorized generics are branded drugs sold under their generic names at a reduced price.