Coria launches Acanya Gel pump
BRIDGEWATER, N.J. — A drug made by Coria Labs for treating acne now is available in a convenient, ready-to-use pump, the drug maker said Monday.
Coria announced the availability of the Acanya Gel (clindamycin phosphate and benzoyl peroxide) pump in the 1.2%/2.5% strength for acne vulgarism.
The drug is the only Food and Drug Administration-approved once-daily combination of an antibiotic and benzoyl peroxide for treating inflammatory and non-inflammatory acne, the company said.
FDA approves generic versions of Zyprexa
SILVER SPRING, Md. — The Food and Drug Administration has approved the first generic versions of two drugs made by Eli Lilly for treating schizophrenia and bipolar disorder, the agency said Monday.
The FDA announced the approval of generic olanzapine tablets and olanzapine orally disintegrating tablets, respectively generic versions of Lilly’s Zyprexa and Zyprexa Zydus. Dr. Reddy’s Labs and Teva Pharmaceuticals USA will manufacture olanzapine tablets, while Dr. Reddy’s, Apotex and Par Pharmaceuticals will manufacture the orally disintegrating version.
"The approval of generic olanzapine offers greater access to a widely used treatment for mental illness," FDA Office of Pharmaceutical Science deputy director Keith Webber said. "Having affordable treatment options is good for patients with long-term illnesses that must be carefully managed."
On Thursday, Prasco Labs announced that it would partner with Lilly to make authorized generic versions of Zyprexa and Zyprexa Zydus, scheduled to launch at the same time as the generic versions. An authorized generic drug is the branded drug marketed under its generic name at a reduced price.
CMS needs fair definition of AMP
WHAT IT MEANS AND WHY IT’S IMPORTANT — When CMS withdrew its proposed AMP rule about a year ago, it should have included the sections pertaining to how federal upper limits were calculated — that is, assuming you are using AMP to come up with those FULs. That’s a pretty good argument for throwing out the draft FULs CMS published last week. How can you solve X plus no less than 175% if you’re not really settled on what X equals?
(THE NEWS: NACDS expresses concerns with new FUL list for pharmacy Medicaid reimbursement. For the full story, click here)
That’s a problem because smaller, independent pharmacies could be facing reimbursement cuts of up to 38% to 44%, according to the National Community Pharmacists Association. And its not just mom and pop shops that lack the buying power of a big chain — according to NCPA, the typical independent’s average acquisition costs are about 25% to 50% higher than the average publicly held pharmacy chain — that would get hurt by all this. "After a comprehensive analysis, one [National Association of Chain Drug Stores] member company found that more than half of the draft FULs were below the pharmacy’s cost to acquire these products from a wholesaler," NACDS noted in a Oct. 21 letter to CMS.
First, CMS needs to settle on a fair definition of AMP is before it can determine the minimum amount it will pay pharmacies to dispense drugs to Medicaid patients. According to analysis conducted by Pembroke Consulting, nearly two-thirds of the drugs published in the original AMP data, were being sold by their manufacturers for less than 25 cents a pill — 175% up 25 cents or less doesn’t add up to what a pharmacy will pay for that pill.