ReportersNotebook — Chain Pharmacy, 10/10/11
SUPPLIER NEWS — The Food and Drug Administration has approved Mylan’s promethazine hydrochloride tablets, a generic drug for treating allergies, in the 12.5-mg, 25-mg and 50-mg strengths. Promethazine hydrochloride tablets, which are manufactured by several companies, had sales of about $42 million during the 12-month period ended in June, according to IMS Health.
Sandoz, the generic drugs arm of Swiss drug maker Novartis, announced the FDA approval of Omnitrope (somatropin [rDNA origin]) for children with growth failure due to Turner syndrome. Sandoz said Omnitrope was now approved for all the same indications as the reference product, Pfizer’s Genotropin.
Omnitrope originally received approval from the FDA for pediatric growth-related disorders in 2006 under a new drug application. Though Omnitrope technically is a follow-on biologic, no abbreviated approval pathway for follow-on biologics existed at the time.
The FDA approved a generic skeletal muscle relaxant made by Sagent Pharmaceuticals, Sagent said. The generic drug maker will offer orphenadrine citrate injection in 60 mg/2 mL, single-dose vials. Various versions of the drug had sales of about $4.3 million in 2011, according to IMS Health.
Amgen announced the FDA’s approval of the biotech drug Prolia (denosumab) for increasing bone mass in men and women who are at risk of fractures due to hormone ablation treatments they are receiving for prostate and breast cancer, respectively. “Bone loss and fractures are recognized adverse effects of hormone ablation therapies, but we have not had an approved treatment option to prevent these problems for our patients,” Massachusetts General Hospital Cancer Center genitourinary malignancies program head Matthew Smith said.
A drug made by Boehringer Ingelheim and Eli Lilly showed “meaningful and durable” reductions in blood sugar in adults with Type 2 diabetes, according to results of a late-stage clinical trial presented at a conference in Europe. BI and Lilly presented data from their 2,121-patient, 102-week phase-3 study of Tradjenta (linagliptin) at the European Association for the Study of Diabetes’ 47th annual meeting in Lisbon, Portugal, showing that the drug, combined with other drugs, lowered HbA1C levels by 0.8% over the long term.
PhRMA: 900+ biotech drugs in development
WASHINGTON — Drug makers have 901 biotech drugs under development for more than 100 diseases ranging from cancers and infectious diseases to autoimmune disorders and cardiovascular diseases, the Pharmaceutical Research and Manufacturers of America said.
Cancer drugs, in particular, have seen tremendous activity, with 353 drugs for cancer and related conditions included on the list. The list also included 69 drugs for autoimmune diseases, 187 for infectious diseases and 59 for cardiovascular diseases. They included 300 monoclonal antibodies, 298 vaccines, 20 interferons and 23 antisense drugs.
“Innovative, targeted therapies offer enormous potential to address unmet medical needs of patients with cancer, HIV/AIDS and many other serious diseases,” PhRMA president and CEO John Castellani said.
NCPA, NACDS to Congress: Drug stores save U.S. money
A group representing independent pharmacies is urging Congress to cut the deficit by reducing healthcare expenditures, but “without compromising patients’ access to their pharmacy of choice or harming local jobs.” In a letter sent last month to the Joint Select Committee on Deficit Reduction, the National Community Pharmacists Association suggested increasing use of generic drugs, encouraging such services as medication therapy management, collecting manufacturer rebates, and allowing patients to choose their pharmacies and avoid requirements to use mail-order services. These measures, the NCPA said, could reduce spending on drugs and increase medication adherence.
“We believe that significant savings can be found through simple reforms to programs like Medicare and Medicaid that will result in reduced drug costs for the federal government and consumers,” NCPA CEO and EVP Douglas Hoey said. “Nothing can save the health system more money than the appropriate use of generic medications. Local pharmacists are leading the way on the proper use of these cost-cutting drugs.”
Meanwhile, the National Association of Chain Drug Stores sent a letter to the same committee, calling for moves to increase medication adherence and urging collaboration with community pharmacy in developing solutions to curb healthcare costs, while at the same time maintaining patient access to prescription medications and pharmacy services. Highlighting the accessibility of local pharmacists, the letter urged improved medication adherence as key to improved health and reduced costs.