The Weekly Mortar & Pestle A Publication of Walgreens Health Initiatives March 6, 2008 A publication created especially for our clients and associates, delivering up-to-date information about brand-name and generic medication, medical products, and other pharmaceutical-related information collected from key government and industry sources. Recent Food and Drug Administration () warnings and health news for patients and healthcare professionals Drug/Issue News Event(s) Member/Client Impact Belladonna and opium Low (B&O) suppositories/ multiple Issue: Drug shortage update 02/27/08 Paddock had B&O suppositories on back order due to problems obtaining raw materials, but the problems have been resolved. Paddock estimates availability by the end of March. B&O Supprettes by Amerifit is on back order because it is an unapproved drug, and the company must submit an approval application to continue marketing. Amerifit will not estimate a release date. Strategic Rationale Low utilization. Supply is expected to meet demand. Action Needed to Implement Communication to clients via Weekly M&P newsletter. The accuracy and completeness of the content herein are not guaranteed by Walgreen Co. or its affiliates and subsidiaries. Content not to be construed as a solicitation or recommendation. Brand names are the property of their respective owners. 2007 Walgreens Health Initiatives. All rights reserved. 1
Drug/Issue News Event(s) Member/Client Impact Teslac (testolactone) Low tablets/bristol-myers Squibb Issue: Drug discontinuation Tysabri (natalizumab) injection/biogen Idec, Inc. Issue: Safety alert 2/28/08 Teslac will no longer be manufactured or sold once existing supplies have been depleted. The discontinuation is not because of safety issues but due to changes in market demand. Healthcare professionals should transition patients to alternative therapies in anticipation of discontinuation. 02/27/08 Significant liver injury has been reported in patients receiving Tysabri, occurring as early as six days after the first dose. Patients should call their doctor immediately if they are experiencing symptoms of liver injury, such as yellowing of the skin or eyes, nausea, vomiting, darkened urine, or fatigue. Before initiation of therapy, patients should be informed that Tysabri may cause liver injury, and therapy should be discontinued in patients with jaundice or other evidence of significant liver injury. Tysabri is indicated for the treatment of multiple sclerosis and is currently available only through a restricted distribution program, known as TOUCH. Low Strategic Rationale Very low utilization. Affected members should discuss alternatives with their physicians. Risk of liver injury was previously known to health care professionals. The safety alert will serve to reinforce that knowledge. Action Needed to Implement Communication to clients via Weekly M&P newsletter. MedMonitor will update conflict edits and drug lists as needed. Communication to clients via Weekly M&P newsletter. 2
Drug/Issue News Event(s) Member/Client Impact Xopenex (levalbuterol) 02/26/08 Because of manufacturing delays, the Low 1.25mg/0.5mL unit dose unit dose vials are on back order, with vials/sepracor an estimated release date in mid-april. No other Xopenex products are Issue: Drug shortage affected. The 1.25mg/3mL unit dose vials can be used in place of the backordered unit dose vials. Strategic Rationale Very low utilization. Supply is expected to meet demand. Action Needed to Implement Communication to clients via Weekly M&P newsletter. New Products* Drug/Manufacturer Arcalyst (rilonacept) injection/regeneron Pharmaceuticals Xyntha (antihemophilic factor [recombinant]) injection/wyeth Prezista (darunavir) 600 mg tablets/tibotec Antiinflammatory Antihemophilia Indication(s) Projected Launch New -Approved Agents Treatment of 02/27/08 First cryopyrinassociated quarter of periodic 2008 syndromes (CAPS) disorders Treatment of hemophilia A Arcalyst is an orphan drug that is the first available for CAPS, a group of rare, inherited autoinflammatory conditions. 02/21/08 Unknown Xyntha is a genetically engineered antihemophilic effective in preventing and controlling bleeding. New Dosage Forms & Combinations Anti-HIV Treatment of HIV 02/27/08 May 2008 The new strength reduces the number of tablets patients must take each day. The 300 mg tablets will still be available. Programs Planned Specialty to evaluate. Specialty to evaluate. Preferred class. MedMonitor will update conflict edits and drug lists as needed. 3
Drug/Manufacturer Nexium (esomeprazole) 10 mg delayed-release oral suspension/astrazeneca Humira (adalimumab) injection/ Abbott Avastin (bevacizumab) injection/genentech Gastrointestinal Antiinflammatory Anti-cancer Indication(s) Projected Launch New -Approved Indications Treatment of 02/27/08 Unknown The dose will be 10 mg gastroesophageal to 20 mg daily for reflux disease in children aged 1 to 11. children aged 1 to Nexium is also available 11 in delayed-release capsules and in 20 mg and 40 mg delayedrelease oral suspension. Treatment of moderately to severely active polyarticular juvenile rheumatoid arthritis in patients age 4 and older Treatment of metastatic breast cancer New First-Time Generic Drug s None to Report * Note: If -approved, s are under P&T review and reside on the 3 rd tier. 02/21/08 Available Humira is also indicated for ankylosing spondylitis, Crohn s disease, psoriatic arthritis, rheumatoid arthritis in adults, and plaque psoriasis. 02/22/08 Available Avastin is also indicated for the treatment of colorectal cancer and non-small cell lung cancer. Programs Planned All dosage forms of Nexium are nonpreferred. MedMonitor will review for conflict edit updates. OTC Prilosec Step Care in place. Humira is a preferred. No changes planned. Biologic Response Modifier SPA in place. No effect on PBM. 4
Analysis Drug/Manufacturer Indication(s) Status Durezol (difluprednate) 0.05% ophthalmic emulsion/ Sirion s Effient (prasugrel) tablets/ Daiichi Sankyo and Eli Lilly Milnacipran capsules/ Forest Laboratories and Cypress Bioscience Sabril (vigabatrin) tablets/ Ovation Pharmaceuticals Zentase (pancrelipase) capsules/eurand Anti-inflammatory Platelet inhibitor Treatment of postoperative ocular inflammation Treatment of acute coronary syndromes for patients being managed with percutaneous coronary intervention New drug application (NDA) accepted. NDA accepted and priority review granted. Durezol is a topical ophthalmic steroid. Studies have shown that Effient prevents more heart attacks than Plavix (clopidogrel), but is associated with higher rates of major bleeding. Antidepressant Treatment of fibromyalgia NDA accepted. The anticipate a decision from the by October 2008. Trade name has not been determined. Anticonvulsant Gastrointestinal Treatment of infantile spasms and refractory complex partial seizures Treatment of exocrine pancreatic insufficiency First-Time Generic Drugs in the None to Report NDA accepted. NDA accepted. Currently, there are no anticonvulsants available for the treatment of infantile spasms. Zentase is biologically similar to endogenous human pancreatic secretions necessary for proper human digestion. 5
New Generics Log (Recent updates are noted in blue.) Generic Albuterol extendedrelease tablets/mylan Alendronate tablets/ multiple Amlodipine tablets/mylan Amlodipine/ benazepril capsules/teva Beta-adrenergic (bronchodilator) Osteoporosis (calcium channel blocker) (ACE-inhibitor/ calcium channel blocker combination) Release * VoSpire ER Approved 01/29/07 02/02/07 Fosamax Late Tentative TBD Patent expired February 6, 2008. Merck will launch an authorized generic. Norvasc Approved 03/23/07 04/03/07 Lotrel Approved, with the exception of Lotrel 5/40 and 10/40 strengths. 05/18/07 05/22/07 Shipments resumed after temporary injunction, but Sandoz plans its own generic. Litigation is ongoing. Lotrel 5/40 and 10/40 remain preferred. Atorvastatin tablets Cholesterol Lipitor Early TBD TBD Anticipated availability in 2010. Patent expires March 2010. Budesonide/ formoterol inhalation Carvedilol tablets/taro Antiasthmatic (beta-blocker) Symbicort Early TBD TBD Patent expires December 2012. Coreg Approved 09/05/07 09/11/07 6
Generic Cetirizine tablets and syrup/multiple Clopidogrel tablets/ Apotex Dexmethylphenidate extended-release (ER) capsules/barr Diltiazem extendedrelease tablets/andrx Escitalopram tablets/ IVAX Esomeprazole capsules/ Ranbaxy Ezetimibe/ simvastatin tablets Nonsedating antihistamine Release * Zyrtec Approved 12/27/07 January 2008 Cetirizine will be available OTC. Brand Zyrtec OTC products, marketed by Johnson & Johnson, became available in January 2008. Liquid formulation is available as brand Zyrtec, generic, and OTC. All other formulations will be available OTC. Platelet inhibitor Plavix Approved 01/20/06 August 2006, Patent litigation upheld. then withdrawn Patent expires in 2011. Attention deficit Focalin XR Early TBD TBD Patent litigation is ongoing. hyperactivity disorder Blood pressure Antidepressant Gastric acid secretion reducer Cardizem LA Early TBD TBD Andrx will not market until 4/1/09, per agreement with Biovail. Lexapro Approved 02/06/07 TBD Patent litigation upheld. Patent expires in 2012. Nexium Late Tentative TBD Patent litigation is pending. Ranbaxy could launch at risk in April 2008. Cholesterol Vytorin Early TBD TBD Patent expires September 2013. 7
Generic Famciclovir tablets/ Teva Fluticasone/ salmeterol powder for inhalation Fluvastatin capsules and fluvastatin extended-release tablets Formoterol powder for inhalation Granisetron tablets/ Barr Lansoprazole delayed-release capsules/teva Losartan tablets/lek Metoprolol extended-release tablets/kv Pharm and Sandoz Release * Antiviral Famvir Approved 08/24/07 Teva was allowed by court order to resume marketing in late September 2007. Antiasthmatic Cholesterol Litigation ongoing. Advair Early TBD TBD Patent expires September Diskus 2010. Lescol and Lescol XL Early TBD TBD Patent expires April 2012. Antiasthmatic Foradil Early TBD TBD Patent expires December Aerolizer 2016. Anti-emetic Kytril Approved 12/28/07 January 2008 Patent expired 12/28/07. Gastric acid secretion reducer (angiotensin receptor blocker) (beta-blocker) Prevacid Late Tentative TBD Teva is currently in patent litigation concerning the generic, and a court decision is expected before June 2008. Cozaar Late Tentative TBD Patent protection ends August 2009. Toprol XL Approved 05/18/07 Available 8
Generic Modafinil tablets/multiple Ofloxacin 0.3% otic solution/apotex Omeprazole delayed-release tablets/dexcel Pantoprazole delayed-release tablets/teva Release * Narcolepsy Provigil Late Tentative TBD Patent protection ended November 2007. Antibiotic Floxin Otic Approved Available Apotex will have a 180- day marketing exclusivity for this product Anti-ulcer Prilosec Late Tentative TBD Litigation is ongoing. OTC Anti-ulcer Protonix Approved 08/02/07 Teva began initial shipment on 12/24/07 but agreed to halt until 1/30/07 to resume settlement talks with Wyeth. Caraco launched its generic on 1/30/08, and is currently in patent litigation with Wyeth. Wyeth launched its generic Protonix, distributed by Prasco on 1/29/08. Teva did not relaunch and does not plan to do so. Teva will share 180- day marketing exclusivity with Caraco. With Wyeth supplying its own generic product, the supply is expected to meet demand. Wyeth will continue to pursue patent infringement claims against Teva and Caraco. 9
Generic Paroxetine extendedrelease tablets/mylan Pramipexole tablets/barr Propranolol extended-release capsules/par Ramipril tablets/tbd Repaglinide tablets/ Caraco Risperidone tablets and solution/pliva Rivastigmine capsules/dr. Reddy s Laboratories (DRL) Rosiglitazone tablets/teva Antidepressant Antiparkinson beta-blocker ACE-inhibitor Antidiabetic Antipsychotic Alzheimer s Antidiabetic Paxil CR Approved 06/29/07 TBD Mirapex Approved 02/19/08 TBD Release * Inderal LA Approved 01/26/07 02/02/07 Protonix patent will expire in July 2010 but may be extended to January 2011 with pediatric exclusivity. Altace Approved 10/24/200 01/09/08 Generic ramipril was 5 launched by Cobalt. Prandin Late Tentative TBD Risperdal Late Tentative TBD Pediatric exclusivity expires June 2008. Exelon Approved 10/31/07 Launch suspended until 2014. Avandia Early Tentative TBD Under the settlement reached between Teva and GlaxoSmithKline, Teva is allowed to launch the generic in the first quarter of 2012. 10
Generic Rosiglitazone/ metformin tablets/teva Antidiabetic Release * Avandamet Early Tentative TBD Under the settlement reached between Teva and GlaxoSmithKline, Teva is allowed to launch the generic in the first quarter of 2012. Rosiglitazone/glime piride tablets/teva Antidiabetic Avandaryl Early TBD TBD Under the settlement reached between Teva and GlaxoSmithKline, Teva is allowed to launch the generic in the first quarter of 2012. Rosuvastatin tablets Cholesterol Crestor Early TBD TBD Patent expires January Salmeterol powder for inhalation Sildenafil tablets/teva Sumatriptan injection and tablets/multiple Tamsulosin capsules/ multiple Terbinafine tablets and topical cream/multiple 2016. Serevent Early TBD TBD Patent expires September Diskus 2010. Viagra Late Tentative TBD Antiasthmatic Erectile dysfunction Migraine Imitrex Late Tentative TBD Ranbaxy settled all matters with GlaxoSmithKline, and generic launch is anticipated in December 2008. Urologic Flomax Late Tentative TBD Patent expires 10/27/09. Antifungal Lamisil Approved 7/2/07 7/10/07 11
Generic Valacyclovir tablets/ranbaxy Valsartan tablets/ranbaxy Venlafaxine extended-release capsules/sun Pharmaceuticals Zaleplon capsules/ multiple Zolpidem tablets/ranbaxy Release * Antiviral Valtrex Approved 01/31/07 TBD Litigation dismissed; product to be marketed late 2009. angiotensin receptor blocker Diovan Late Tentative TBD Patent protection ends September 2012. Antidepressant Effexor XR Early TBD TBD Sun Pharmaceuticals obtained permission from Wyeth, the innovator of Effexor XR, and will submit an abbreviated new drug application. Insomnia Sonata Mid Tentative TBD Anticipated availability in 2008. Insomnia Ambien Approved 04/23/07 04/23/07 *Release date means availability of NDCs for use in Walgreens system. Actual availability on shelves may occur after NDCs are released. Information for Mortar & Pestle is obtained from the following sources (with secondary-source links provided): Food and Drug Administration (www.fda.gov) American Society of Health-Systems Pharmacists (www.ashp.org) P&T Community (www.ptcommunity.com) Pharmaceutical News Harvest (www.internetdrugnews.com) Drugs.com (www.drugs.com) Pharmacy OneSource (www.pharmacyonesource.com) 12