FDA OKs continued compounding of versions of Makena
SILVER SPRING, Md. — Usually, when the Food and Drug Administration approves a commercial version of a drug, it prohibits compounding pharmacies from producing it, but it’s making an exception in the case of a drug used to prevent premature births.
In February, the FDA approved KV Pharmaceuticals’ Makena (hydroxyprogesterone caproate), an injectable drug widely available in compounding pharmacies. But with Makena costing $1,500 per dose — compared with $10 to $20 for compounded versions of hydroxyprogesterone caproate, also known as 17P — the FDA is permitting compounding pharmacies to continue preparing and dispensing the treatment.
KV had sent letters to pharmacists saying that the FDA no longer would allow them to make compounded versions of 17P, though the FDA said this was not correct.
“We applaud the FDA’s decision,” said George Malmberg, president and CEO of Wedgewood Pharmacy, a compounding pharmacy based in Swedesboro, N.J. “As compounding pharmacy specialists, we have provided physicians and their patients with the compounded version of 17P for many years. Like all concerned, we are committed to making sure that patients at risk have access to this life-saving medication.”
The Society for Maternal-Fetal Medicine praised the FDA’s decision as well. “This action will ensure that this life-saving treatment will continue to be available for all those who need it,” SMFM president George Saade said. “Affordable access to hydroxyprogesterone caproate is critical to ensuring the health and full-term birth of babies in the [United States].”
Aurobindo receives approval for generic Razadyne, Monopril
HYDERABAD, India — Indian generic drug maker Aurobindo has received two approvals from the Food and Drug Administration.
The company said Wednesday that it received approval for galantamine tablets in the 4-, 8- and 12-mg strengths. The drug is a version of Johnson & Johnson’s Alzheimer’s treatment Razadyne; various versions of the drug had sales of $41 million during the 12 months ended in September 2010, according to IMS Health.
On Thursday, the FDA approved Aurobindo’s fosinopril sodium tablets in the 10-, 20- and 40-mg strengths. The drug is a generic version of Bristol-Myers Squibb’s Monopril and is used to treat hypertension. Versions of the drug had sales of $20 million during the 12-month period ended in September 2010, according to IMS.
High blood-glucose levels linked to retinopathy
NEW YORK — Patients diagnosed with high blood-glucose levels that cannot control the condition over time likely will develop such eye-related complications as retinopathy 10 years later, according to a report in the February issue of Archives of Ophthalmology.
A study led by Pascale Massin of Hôpital Lariboisière in Paris and colleagues found that after examining the retinas of 700 men and women — noting that 235 patients had diabetes, 227 patients had an impaired fasting plasma glucose level and 238 patients always had glucose levels within normal limits — 44 participants were classified as having retinopathy, including 19 patients with diabetes, 19 patients with impaired fasting glucose levels and six patients with normal glucose levels. What’s more, those with the retinopathy had higher average levels of fasting plasma glucose 10 years prior (130 mg versus 106 mg per deciliter) and higher HbA1C levels (6.4% versus 5.7%).
"Levels of HbA1C and fasting plasma glucose at baseline were related to the presence of retinopathy 10 years later, and the levels at which the positive predictive values increased provide a rationale for the choice of thresholds for the definition of hyperglycemia associated with 10-year retinopathy," the authors wrote. "Factors other than glucose measures play only a minor role in retinopathy."