Dey launches new COPD drug
NAPA, Calif. Dey, a subsidiary of Mylan has launched a new drug for the treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease.
The Perforomist Inhalation Solution will be used with a nebulizer that converts the powder into a mist that patients inhale through a mouthpiece or facemask. The medication is prescribed to be taken twice daily, once in the morning and again in the evening.
“Since patients have difficulty adhering to complicated medication regimens, it’s very helpful that Perforomist Inhalation Solution offers a twice-daily nebulized version of formoterol. I consider nebulization to be an especially effective way to deliver medication into the lungs, and this new product should provide a valuable treatment for COPD patients,” said to Donald Tashkin, professor of medicine at the David Geffen School of Medicine of UCLA.
COPD is the fourth leading cause of death in America, killing about 120,000 people each year.
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 approves Ixempra for breast cancer
WASHINGTON The Food and Drug Administration has approved Bristol-Myers Squibb’s Ixempra monotherapy for the treatment of patients with metastatic or locally advanced breast cancer whose tumors are resistant or refractory to anthracyclines, taxanes and capecitabine.
The FDA has also granted approval of Ixempra in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to an anthracycline and a taxane or whose cancer is taxane-resistant and for whom further anthracycline therapy is contraindicated.
BMS anticipates Ixempra will be available soon.