FDA approves label changes for Accutane and its generics
The Food and Drug Administration has approved label changes to Roche’s acne medication Accutane and its generic isotretinoin, manufactured by Barr Laboratories, Genpharm/Mylan Pharmaceuticals and Ranbaxy Laboratories.
The label changes were made to improve the management of the iPledge pregnancy risk management program. Pregnant women are not allowed to take the medication due to risk of birth defects.
Roche, who proposed the changes, said they are intended to enhance the flexibility of the iPledge program, reduce interruptions in treatment and reduce the burden on patients, prescribers and pharmacies, thereby making the program more consistent with the way prescribers function.
The changes are planned to go into effect on Dec. 2.
FDA supports Medicare rule on anemia drugs
WASHINGTON The Food and Drug Administration is agreeing with Medicare on restrictions for government payments for anemia drugs made by Amgen and Johnson & Johnson, according to Bloomberg.
Payment rules set by Medicare, are “generally consistent’’ with prescribing information for use of the drugs in cancer patients, the Food and Drug Administration said in a letter released today by Representatives Pete Stark and Henry Waxman.
Medicare said back in July that they would not pay for the drugs, Epogen, Aranesp, and Procrit used in cancer patients with hemoglobin levels exceeding 10 grams a deciliter. The companies are trying to convince Medicare that the drugs were safe to use up to 13 grams.
U.S. sales of Amgen’s Aranesp fell 19 percent in the second quarter after the FDA warned doctors to dispense the lowest doses possible to minimize heart risks. Sales of Johnson & Johnson’s Procrit fell 15 percent in the third quarter.
My Clinic to open 12 clinics nationwide
HOUSTON Intrepid Holdings, founder of My Healthy Access, announced that subsidiary My Clinic company has opened twelve new retail clinic models in a national retail pharmacy chain, the company said Tuesday.
The first of these clinics, located in Illinois, Indiana and Ohio will provide care for non-threatening medical conditions, the company said. Certified nurse practitioners or physician assistants will provide care with physician oversight.
A leading provider of clinic, pharmacy and related healthcare services to the urban marketplace, Intrepid Holdings believes that these clinics will provide greater access to quality, convenient and affordable healthcare for non-emergency conditions such as pink eye, colds, and ear and eye infections.
“My Clinic offers patients access to a quality, convenient and affordable healthcare solution in their local community retail pharmacies that they trust and depend on for their prescription needs,” said Toney Means, president of Intrepid Holdings and chief executive officer the Clinic Group. “These patients now have the opportunity to receive quality, affordable and convenient medical care for non emergency episodic conditions in their local community pharmacy.”
Intrepid’s My Healthy Access currently operates clinics in select Wal-Mart supercenters in Houston.