Generic News 8.25.14

Author: APCI Staff/Tuesday, August 26, 2014/Categories: Generics and Vendor Contracting, Generic Bulletins

Tramadol Schedule change – The notice below was sent out last week.

Due to these changes some of these items were not on contract from August 18 – August 23, 2014.

The contract pricing is now available.

Items were supposed to be on contract from Aug 18th – August 23rd. Orders affected will be credited and rebilled to reflect contract pricing. The processing should occur within the coming weeks.

For reference, the following are the products that were intended to be on OneStop:

Item # NDC # Description GNRC ID Dose Form Add to OS

3209277

49884082111

TRAMADOL ER TAB 100MG PAR 30@

26387

TAB ER 24H

8/23/2014

3209285

49884082211

TRAMADOL ER TAB 200MG PAR 30@

50417

TAB ER 24H

8/23/2014

3209293

49884082311

TRAMADOL ER TAB 300MG PAR 30@

50427

TAB ER 24H

8/23/2014

3209301

10370022311

TRAMADOL TB ER 300MG PAR 30@

99153

TBMP 24HR

8/23/2014

3209319

10370022111

TRAMADOL TB ER 100MG PAR 30@

99151

TBMP 24HR

8/23/2014

3209327

10370022211

TRAMADOL TB ER 200MG PAR 30@

99152

TBMP 24HR

8/23/2014

3216140

63739067110

TRAMADOL TAB 50MG SKY UD 100@

7221

TABLET

8/23/2014

These items will be added to the contract effective 8/27/14 – Credit/Rebills will be processed for these items as well:

Item NDC Description
3209426 53746061701 TRAMADOL+ACET 37.5/325 AMN100@
3209418 53746061705 TRAMADOL APAP TB 325MG AMN500@

**Reprint** (Notice sent out last week):

McKesson UPDATE: Regarding tramadol as a schedule IV controlled substance:

Effective August 18, 2014, the Drug Enforcement Administration (DEA) will place tramadol into schedule IV of the federal Controlled Substances Act. McKesson has set up new item numbers for all active tramadol SKUs in advance of the switch to controlled substance status. The new item numbers will not be available for ordering until Tuesday, August 19. The old item numbers were discontinued effective Thursday, August 14. Tramadol will not be available for order from Friday, August 15 through Monday, August 18.

Please see below for the new item numbers. The NDC numbers for these products are not changing (except for Lupin Pharmaceuticals’ products – see below), only the item numbers and labels. We expect to have sufficient supply of most of the newly-labeled products within a week of the change.

Old Item #

Old NDC #

New Item #

New NDC # (if applicable)

Supplier Name

Item Description

1140938 68084049601 3216249 AMERICAN HEALTH PACKAG TRAMADOL+ACE 37.5/325 UDAHP100
1815414 62584055901 3216090 AMERICAN HEALTH PACKA TRAMADOL TB 50MG UD AHP 100
1377860 65162062710 3209384 AMNEAL PHARMACEUTICALS TRAMADOL TAB 50MG AKY 100@
1379700 65162062711 3209392 AMNEAL PHARMACEUTICALS TRAMADOL TAB 50MG AKY 1000@
1381367 65162062750 3209400 AMNEAL PHARMACEUTICALS TRAMADOL TAB 50MG AKY 500@
2580777 53746061705 3209418 AMNEAL PHARMACEUTICALS TRAMADOL APAP TB 325MG AMN50
2580785 53746061701 3209426 AMNEAL PHARMACEUTICALS TRAMADOL+ACET 37.5/325 AMN100@
2157527 68180038306 3213907 6818069706 LUPIN PHARMACEUTICALS TRAMADOL ER TAB 100MG LUPI 30
2157535 68180038406 3214095 6818069806 LUPIN PHARMACEUTICALS TRAMADOL ER TAB 200MG LUPI 30
2157543 68180038506 3214384 6818069906 LUPIN PHARMACEUTICALS TRAMADOL ER TAB 300MG LUPI 30
2055960 00904636561 3216132 MAJOR PHARMACEUTICALS TRAMADOL TAB 50MG UD MMP 100
1292614 10135051901 3211901 MARLEX PHARMACUTICALS TRAMADOL TAB 50MG MARL 100
1292945 10135051910 3212099 MARLEX PHARMACUTICALS TRAMADOL TAB 50MG MARL 1000
2046829 63739067110 3216140 MCK PKG SVCS/AMNEAL TRAMADOL TAB 50MG SKY UD 100@
1394303 51079099156 3209533 MYLAN INSTITUTIONAL INC @ TRAMADOL TB 50MG UD UDL PC300@
1451590 51079099120 3209566 MYLAN INSTITUTIONAL INC @ TRAMADOL TAB 50MG UD UDL 100@
1447226 00378415105 3209541 MYLAN PHARMACEUTICALS @ TRAMADOL TAB 50MG MYLN 500@
1447424 00378415101 3209558 MYLAN PHARMACEUTICALS @ TRAMADOL TAB 50MG MYLN 100@
3244142 00378808801 3209574 MYLAN PHARMACEUTICALS @ TRAMADOL APAP 37.5/325MYLN100@
1822097 16714011110 3209582 NORTHSTAR RX LLC TRAMADOL TAB 50MG 100 NSTAR@
1822907 16714011111 3209590 NORTHSTAR RX LLC TRAMADOL TAB 50MG 500 NSTAR@
1823095 16714011112 3209608 NORTHSTAR RX LLC TRAMADOL TAB 50MG 1000 NSTAR@
1401421 49884094605 3209251 PAR PHARMACEUTICAL INC @ TRAMADOL+ACET 37.5/325 PAR500@
1417831 49884094601 3209269 PAR PHARMACEUTICAL INC @ TRAMADOL+ACET 37.5/325 PAR100@
1823681 49884082111 3209277 PAR PHARMACEUTICAL INC @ TRAMADOL ER TAB 100MG PAR 30@
1824010 49884082211 3209285 PAR PHARMACEUTICAL INC @ TRAMADOL ER TAB 200MG PAR 30@
1955848 49884082311 3209293 PAR PHARMACEUTICAL INC @ TRAMADOL ER TAB 300MG PAR 30@
2200418 10370022311 3209301 PAR PHARMACEUTICAL INC @ TRAMADOL TB ER 300MG PAR 30@
2232692 10370022111 3209319 PAR PHARMACEUTICAL INC @ TRAMADOL TB ER 100MG PAR 30@
2232700 10370022211 3209327 PAR PHARMACEUTICAL INC @ TRAMADOL TB ER 200MG PAR 30@
1272541 10147090103 3216033 PATRIOT PHARMACEUTICALS TRAMADOL ER TB 100MG PATR 30@
1272582 10147090203 3216041 PATRIOT PHARMACEUTICALS TRAMADOL ER TB 200MG PATR 30@
1272715 10147090303 3215977 PATRIOT PHARMACEUTICALS TRAMADOL TAB ER 300MG PATR 30@
1107135 57664037718 3209145 SUN PHARMACEUTICALS @ TRAMADOL TAB 50MG CARA 1000@
1443969 57664037708 3209152 SUN PHARMACEUTICALS @ TRAMADOL TAB 50MG CARA 100@
1444264 57664037713 3209160 SUN PHARMACEUTICALS @ TRAMADOL TAB 50MG CARA 500@
2199602 47335053183 3209178 SUN PHARMACEUTICALS @ TRAMADOL ER TB 100MG CARA 30@
2199842 47335053383 3209186 SUN PHARMACEUTICALS @ TRAMADOL ER TB 200MG CARA 30@
2199859 47335053783 3209194 SUN PHARMACEUTICALS @ TRAMADOL ER TB 300MG CARA 30@
2221844 47335085983 3209202 SUN PHARMACEUTICALS @ TRAMADOL ER TB 100MG CARA 30@
2221885 47335086083 3209210 SUN PHARMACEUTICALS @ TRAMADOL ER TB 200MG CARA 30@
2221893 47335086183 3209228 SUN PHARMACEUTICALS @ TRAMADOL ER TB 300MG CARA 30@
2254878 57664053788 3209236 SUN PHARMACEUTICALS @ TRAMADOL+ACET37.5/325 CARA100@
2254886 57664053718 3209244 SUN PHARMACEUTICALS @ TRAMADOL+ACET37.5/325CARA1000@
1634898 00093005801 3216330 TEVA PHARMA (SICOR) @ TRAMADOL TAB 50MG TEV 100@
1671403 00172635970 3216413 TEVA PHARMA (SICOR) @ TRAMADOL+ACT 37.5/325 IVA 500@
1635176 00093005805 3213097 TEVA PHARMACEUTICALS TRAMADOL TAB 50MG TEV 500
2904233 76439013611 3220803 VIRTUS PHARMACEUTICALS LLC TRAMDOL HCL TAB 50MG VIRT 1000
2151512 68382031910 3216173 ZYDUS PHARMACEUTICALS TRAMADOL TAB 50MG ZYD 1000
2155034 68382031901 3216215 ZYDUS PHARMACEUTICALS TRAMADOL TAB 50MG ZYD 100
1903327 68382033401 3216264 ZYDUS PHARMACEUTICALS @ TRAMADOL+ACET37.5/325 ZYD 100@
1903335 68382033405 3216363 ZYDUS PHARMACEUTICALS @ TRAMADOL+ACET37.5/325 ZYD 500@

Please note; there will be no substitution from the old items to the new items as we do not substitute non-scheduled products to scheduled products.


Price Assurance Promotion – Price Alert

August 22, 2014

Please make note of the following items eligible for the Price Assurance Promotion

Item # Description Top Movers*
2126571 CLOBETAS PRP 0.05% PERR 50GM@ *
2126936 CLOBETAS PRP 0.05% PERR 100GM@ *
1863356 HYDROCORT SUPP 30MG UD PADD12@ *
1276872 ECONAZ NITR CRM 1% PERR 15GM@  
1277151 ECONAZ NITR CRM 1% PERR 30GM@  
1277334 ECONAZ NITR CRM 1% PERR 85GM@  

A customers’ purchase of these 6 item s will be covered by the Price Assurance Promotion for 30 days beginning August 22, 2014, the first day of the invoice price increase.

McKesson has been notified of 3 product families representing 6 items that increase in price on August 22, 2014. Customer purchases of this item are covered by our Price Assurance Promotion for 30 days following this posting. Customers will receive price assurance payments on purchases of eligible product during the 30-day price assurance period, up to a maximum quantity determined by their 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. For more information, please visit the OneStop Generics homepage on McKesson Connect. Note: The percentage increase in the invoice price may vary from the percentage increase in the WAC price. *Top 250 GCN Rank


Generic Bromfed DM addition

On Monday, August 18, Qualitest Products launched the generic equivalent of Bromfed DM® cough syrup (D-methorphan HB/P-EPD HCL/BPM). The Qualitest item will be added to the OneStop program in the primary position with anticipated inventory and visibility in McKesson Connect on Tuesday, August 19.

Brand Items:

Item # NDC # Description
1251958 60432083704 BROMFED DM COUGH SYRP 118ML
1446574 60432083716 BROMFED DM COUGH SYRP 473ML

Product Launch Information - OneStop Add
Bx Name Bromfed DM cough syrup
Bx Supplier Wockhardt USA Inc.
Generic Name D-methorphan HB/P-EPD HCL/BPM
Generic Description D-methorphan HB/P-EPD HCL/BPM cough syrup
Therapeutic Class/Indication 480800 ANTITUSSIVES / generic Bromfed DM is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
FDA Approval Date August 10, 2014
Launch Reason FDA Approval
Launch Exclusivity No
Number of Players 1 at this time
US Brand Sales Estimated annual U.S. brand sales are $14M

Generic Items:

Item #

Supplier Name

NDC

Description

OS Add

AWP*

3230943 QUALITEST PRODUCTS INC PS 64376065740 BROMPHEN MALEATE PSEDMQ/P118ML 08/19/2014 Not Available
3230968 QUALITEST PRODUCTS INC PS 64376065716 BROMPHEN MALEATE PSEDMQ/P473ML 08/19/2014 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®. There will be no ASAP auto shipment of generic Bromfed DM cough syrup due to low brand usage. This is a courtesy announcement and will also appear in the newsletter.



DEA issues final rule on the rescheduling of Hydrocodone Combination Products (Chavis, 2015)

August 22, 2014

WASHINGTON — The Drug Enforcement Administration issued a final rule rescheduling hydrocodone combination products from schedule III to schedule II of the Controlled Substances Act. This final rule imposes the regulatory controls and sanctions applicable to schedule II substances on those who handle HCPs, according to the DEA. The rule is effective beginning Oct.6, 2014.

The CSA puts substances with medical uses into one of four schedules, the DEA said. Substances with the greatest potential for harm and abuse are categorized as schedule II and substances with less potential for harm and abuse are placed in schedules III through V. Schedule I is meant for controlled substances that don't currently have an accepted medical use. HCPs are drugs that contain hydrocodone (a schedule II drug) and specific amounts of other substances, such as acetaminophen or aspirin. “Almost seven million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents,” said DEA administrator Michele Leonhart, “Today’s action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available.” The entire final rule may be reviewed here.


FDA approves smartphone blood-sugar monitor (Salazar, 2015)

August 21, 2014

WASHINGTON — with a newly approved device, diabetics can turn their smartphone into a blood glucose monitor. The Food and Drug Administration cleared South Korean company Philosys’ Gmate SMART blood sugar monitoring device for U.S. marketing on Aug. 15. The device plugs into the headphone Jack on iPhones and iPads and — using the company’s Gmate app — turns the phone or tablet into a blood sugar monitor. "This is an exciting time for Philosys as we continue our efforts to be a technology leader for the diabetes mobile monitoring arena,” Philosys SVP sales Mike Tickle said. “The Gmate SMART will give our customers TeleHealth capabilities with the accuracy and quality they deserve at a cost effective price.”

The app can store blood glucose data over time and users can email it to physicians. Users can also categorize when in the day — before or after a meal, or after exercise — they monitor their blood sugar. The device is about the size of a quarter and doesn’t require any adapters or need to be paired through Bluetooth. The Gmate app is currently only available for iOS devices.


Updates made to the 2013 ACIP recommendations on seasonal influenza vaccines ( Alexander, 2014)

August 21, 2014

WASHINGTON — The Centers for Disease Control and Prevention has announced recommendations of the Advisory Committee on Immunization Practices for the 2014-15 influenza season. The report updates the 2013 recommendations by the Advisory Committee on Immunization Practices regarding use of seasonal influenza vaccines. Updated information for the 2014–15 influenza season includes 1) antigenic composition of U.S. seasonal influenza vaccines; 2) vaccine dose considerations for children aged 6 months through 8 years; and 3) a preference for the use, when immediately available, of live attenuated influenza vaccine for healthy children aged 2 through 8 years, to be implemented as feasible for the 2014–15 season but not later than the 2015–16 season. Information regarding issues related to influenza vaccination not addressed in this report is available in the 2013 ACIP seasonal influenza recommendations. Information in the report reflects discussions during public meetings of ACIP on Feb. 26 and June 25.



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Kevin Etter, Account Manager
443-276-7827




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