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From: Elan Pharmaceutical:
Elan Pharmaceuticals, Inc. is proud to announce our acquisition of the US marketing rights to the entire immediate-release ROXICODONE product line, including ROXICODONE 15 mg and 30 mg tablets.
Elan is now supporting the full distribution and customer service for these products previously carried through Roxane Laboratories. Effective immediately, all orders for Roxicodone should be placed through your wholesaler, and all sales to the pharmacies must be transacted through your wholesaler supply chain.
In addition:
Elan will maintain all chargeback contracts and process charges
Questions you may have about medical and technical product information should be directed to Elan at 1-888-638-7605
We look forward to continuing to work with you to provide high-quality pain-management products, such as ROXICODONE 15 mg and 30 mg tablets, to your customers. If you would like a sales representative to visit you or have further questions regarding a ROXICODONE order, please call 1-800-859-8586.
Oxycodone is a Schedule II drug that may cause tolerance as well as psychological and physical dependence. The most serious risk associated with opiolds, including ROXICODONE, is respiratory depression. In clinical trials (n=191), the most frequently observed adverse reactions (>3%) were nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness. ROXICODONE is contraindicated in patients with: known hypersensitivity to oxycodone; significant respiratory depression; acute or severe bronchial asthma or hypercarbia; and known or suspected paralycticileus.
ROXICODONE 5 mg tablets are indicated for the relief of moderate to moderately severe pain. ROXICODONE 15 mg and 30 mg tablets are indicated for the relief of moderate-to-severe pain for patients who need opioid analgesics.
Please see the full Prescribing Information.
Sincerely,
Joseph Boudreau
Vice President, Trade Relations
Elan Pharmaceuticals, Inc.
|
PRODUCT |
NDC |
PACKAGE SIZE |
|
ROXICODONE 5 mg Tablet (oxycodone hydrochloride) |
0054-8657-24 0054-4657-25 |
4 X 25 Unit Dose 100 EA Bottle |
|
ROXICODONE 15 mg Tablet (oxycodone hydrochloride) |
0054-8658-24 0054-4658-25 |
4 x 25 Unit Dose 100 EA Bottle |
|
ROXICODONE 30 mg Tablet (oxycodone hydrochloride) |
0054-8665-24 0054-4665-25 |
4 x 25 Unit Dose 100 EA Bottle |
|
ROXICODONE Oral Solution 5 mg/ 5 mL |
0054-8782-16 0054-3682-63 |
5 mL 40s Bottle 500 mL Bottle |
|
ROXICODONE Intensol 20 mg/mL |
0054-3683-44 |
30 mL Bottle |
PHARMACY RETURN GOODS POLICY CONTACT ONE BOX RETURN at 800-321-RETURN
Manufacturer: Elan Pharmaceuticals, Inc. (with the addition of Dura Pharmaceuticals, Inc. Products)
Lot numbers and expiration dates are required for credit
Reimbursement Method: Checks issued to nondirect accounts
Reimbursement Dollar Limit: Prior approval required for returns exceeding $5000 in value
Reimbursement Partial Policy: Accepted and credited at 1/4 increments: Credit as % of $ value: 0% - 24% = 0% 25% - 49% = 25% 50% - 74% = 50% 75% - 99% = 75%
Expiration Date Policy: Expired and within 12 months after expiration date
Other information:
This policy applies to nondirect accounts only
No returns for divested products
Original label only and lot and expiration information must be legible readable
Product outside of policy guidelines will not be accepted for return, nor reimbursement allowed
Product involved in a fire sale or bankruptcy is not eligible for return
Checks will be issued within 3 weeks of return
Expired product only
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