Generic News 10.6.14

Author: APCI Staff/Monday, October 6, 2014/Categories: Generic Bulletins

GENERIC NEWS:

Hydrocodone Combination Product Rescheduling

Effective October 6, 2014, Hydrocodone Combination Products (HCPs) will be rescheduled from Schedule III to Schedule II. This change is being made by the DEA due to abuse and diversion concerns.

OVERVIEW

Hydrocodone Combination Products (HCPs) will be rescheduled to CII, effective October 6, 2014. This change is being made by the DEA due to abuse and diversion concerns.

Pharmacists should manage their pharmacy handling, storage and ordering ofHCPs carefully as the effective date for rescheduling approaches – particularly if the pharmacy is ineligible to dispense CII controlled substances.

Below please find detailed information regarding important dates to be aware and process and procedures to consider.

WHAT YOU SHOULD DO NEXT

Take action to prepare for the following key dates:

    • October 2, 2014:
      • Last day to order CIII labeled HCP from McKesson.
    • October 3, 2014:
      • Last delivery day for CIII labeled HCPs ordered by October 2, 2014.
      • Last day for distribution centers to receive CIII labeled HCP returns.
    • October 3-5, 2014: Blackout Period; HCP (CII or CIII) unavailable for order.
    • October 6, 2014: Effective date for HCP rescheduling to CII
      • First day to order CII labeled HCPs.
      • As of this date, HCPs distributed by McKesson will be labeled as CII.
      • All CII labeled HCPs will have a new McKesson item number.
      • All HCP inventory, regardless of labeling, should be managed, stored, handled and dispensed as a CII controlled substance going forward.
    • October 7, 2014: First delivery day for CII labeled HCP ordered on October 6, 2014.

Price Assurance Promotion: Price Alert Effective 10/01/14

Abstract: Price assurance will be provided during the price assurance period for the difference between the new invoice price and the invoice price before the invoice price increase, multiplied by the eligible quantity
Date: 10/01/2014

The items with future price increases are as follows:

ITEM NUMBER DESCRIPTION PRICE PROTECTION START DATE PRICE PROTECTION END DATE TOP MOVERS*
1906809 MINOCYC HYD CAP 50MG AURO 100@ 10/1/2014 10/31/2014  
1906817 MINOCYC HYD CAP 75MG AURO 100@ 10/1/2014 10/31/2014  
1906023 MINOCYCL CAP 100MG AURO 50@ 10/1/2014 10/31/2014  
2750297 VANCOMY VL 10GM BULK HW1 10/1/2014 10/31/2014  
2737195 VANCOMY ADV 1GM HW 10 10/1/2014 10/31/2014  
2732212 VANCOMY ADV VL 500MG HW 10 10/1/2014 10/31/2014  
2732162 VANCOMY FTV 1GM HW 10 10/1/2014 10/31/2014  
2717486 VANCOMY FTV 500MG HW 10 10/1/2014 10/31/2014  
1259969 PACLITAX MDV 6MG/ML HW 50ML 10/1/2014 10/31/2014 *
1259472 PACLITAX MDV 6MG/ML HW 16.7ML 10/1/2014 10/31/2014 *
1225598 VANCOMY VL 5GM BULK HW 1 10/1/2014 10/31/2014  
1718659 ONDANS SDV FT 2MG/ML 2ML HW25 10/1/2014 10/31/2014  
1707736 HEPAR SOD 1MU/ML 10ML H/W 25 10/1/2014 10/31/2014  
3601937 HEPAR SOD 1MU/ML 1ML H/W 25 10/1/2014 10/31/2014  
1326925 CARBOPLAT MDV 10MG/MLMAYN60ML 10/1/2014 10/31/2014  
1204874 CARBOPLAT MDV 10MG/MLMAYN45ML 10/1/2014 10/31/2014  

You will receive a price assurance payment on purchases of eligible product during the 30-day price assurance period, up to a maximum quantity determined by your purchase history. Price assurance will be provided on the difference between the new invoice price and the invoice price before the invoice price increase, multiplied by the eligible quantity.

Visit the OneStop Generics homepage for the more information about the Price Assurance Promotion.

Note: The percentage increase in the invoice price may vary from the percentage increase in the WAC price.

*Top 250 GCN Rank


Regarding generic Exforge® tablets (amlodipine besylate, valsartan):

To representatives of our valued customers and sales team,

On Tuesday, September 30, Par Pharmaceuticals launched the generic equivalent of Exforge® tablets (amlodipine besylate, valsartan). The Par item will in McKesson Connect on Tuesday, September 30. Inventory is anticipated to be available for purchase on Wednesday, October 1.

Brand Items:

Item # NDC # Description
1721620 00078048815 EXFORGE TAB 5/160MG 30
1744614 00078048915 EXFORGE TAB 10/160MG 30
1721638 00078049015 EXFORGE TAB 5/320MG 30
1744622 00078049115 EXFORGE TAB 10/320MG 30

Product Launch Information - OneStop Add

Bx Name Exforge
Bx Supplier Novartis
Generic Name amlodipine besylate,valsartan
Generic Description amlodipine besylate,valsartan tablets
Therapeutic Class/Indication 242808-DIHYDROPYRIDINES / generic Exforge is indicated for the treatment of hypertension, to lower blood pressure.
FDA Approval Date October 1, 2014
Launch Reason Settlement Agreement
Launch Exclusivity Yes
Number of Players 1
US Brand Sales Estimated annual U.S. brand sales are $437M

Generic Items:

Item # Supplier Name NDC Description OS Add AWP*
3288156 PAR PHARMACEUTICALS 49884057411 AMLO/VALSARTB 5MG/160MGPAR30@ 9/30/2014 Not Available
3288180 PAR PHARMACEUTICALS 49884057511 AMLO/VALSARTB 10MG/160MGPAR30@ 9/30/2014 Not Available
3288198 PAR PHARMACEUTICALS 49884057611 AMLO/VALSARTB 5MG/320MGPAR30@ 9/30/2014 Not Available
3288206 PAR PHARMACEUTICALS 49884057711 AMLO/VALSARTB 10MG/320MGPAR30@ 9/30/2014 Not Available

*The SWP and/or AWP in this communication was provided by the manufacturer in connection with the launch of this product. McKesson does not take any responsibility for the setting of SWP and/or AWP or the accuracy of this information. AWP will be available in McKesson Connect as and when this information is received from Wolters Kluwer's Medi-Span®.



APCI VENDOR UPDATES:

Clarification on information in last weeks bulletin regarding pricing on Allison Medical Sure Care products: Pricing provided in the 9/29/14 bulletin was estimated NET PRICING based on rebates paid to APCI’s General Fund. This rebate is distributed to members via dividends. We appologize for any confusion this information may have caused. APCI continues to partner with vendors to bring added value to our members. If you have additional quesiton please contact your APCI Representative.


Mallinckrodt update

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