The Weekly Mortar & Pestle

Transcription

1 The Weekly Mortar & Pestle A Publication of Walgreens Health Initiatives February 7, 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 (Updates to previously printed news are noted in blue.) Drug/Issue News Event(s) Member/Client Impact Strategic Rationale Action Needed to Implement None to report New Products* Drug/Manufacturer Accretropin (somatropin [rdna origin]) subcutaneous injection/cangene Therapeutic Class Growth hormone (GH) Indication(s) Projected Launch New -Approved Agents Treatment of 01/23/08 Unknown Cangene's pediatric growth recombinant human hormone deficiency GH is identical in and Turner syndrome sequence to human growth hormone from the pituitary. Programs Planned P&T review planned. Growth Hormone SPA in place. 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 Walgreens Health Initiatives. All rights reserved. 1

2 Drug/Manufacturer Moxatag (amoxicillin) tablets/ Middlebrook Pharma Emend (fosaprepitant) injection/merck Xyzal (levocetirizine) oral solution Therapeutic Class Antibiotic Anti-nausea Antihistamine Indication(s) Projected Launch New Dosage Forms and Combinations Treatment of 01/23/08 Unknown Moxatag is a tonsillitis/pharyngitis once-daily extendedrelease formulation. Prevention of nausea and vomiting associated with chemotherapy Relief of symptoms associated with allergic rhinitis 01/25/08 Unknown Emend is also available in oral capsules. 01/28/08 Unknown Xyzal is also available in oral tablets. New -Approved Indications None to report 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. Programs Planned P&T review planned. P&T review planned. MedMonitor will review for conflict edits. Oral antiemetics CPA in place. P&T review planned. MedMonitor will update conflict edits. Over-the-counter (OTC) Nonsedating Antihistamine Step Care in place Analysis Drug/Manufacturer Therapeutic Class Indication(s) Status OTC Mevacor (lovastatin) tablets/merck Cholesterol Treatment of hypercholesterolemia Not approvable letter received. First-Time Generic Drugs in the None to report 2 The requested a revised label and additional data to grant marketing approval.

3 New Generics Log (Recent updates are noted in blue.) Generic Therapeutic Class For Brand Albuterol tablets/mylan Alendronate tablets/ multiple Amlodipine tablets/mylan Amlodipine/ benazepril capsules/teva Atorvastatin tablets Budesonide/ formoterol inhalation Carvedilol tablets/taro Beta-adrenergic (bronchodilator) Release * VoSpire Approved 01/29/07 02/02/07 ER Osteoporosis Fosamax Late Tentative TBD Patent expired February 6, Merck will launch an authorized generic. (calcium channel blocker) (ACE-inhibitor/ calcium channel blocker combination) Norvasc Approved 03/23/07 04/03/07 Lotrel Approved, except 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 & 10/40 remain preferred. Cholesterol Lipitor Early TBD TBD Anticipated availability in Patent expires March Antiasthmatic Symbicort Early TBD TBD Patent expires December (beta-blocker) Coreg Approved 09/05/07 09/11/07 3

4 Generic Therapeutic Class For Brand Cetirizine tablets and syrup/ multiple Clopidogrel tablets/ Apotex Dexmethylpheni date extendedrelease (ER) capsules/barr Diltiazem tablets/andrx Escitalopram tablets/ IVAX Ezetimibe/simva statin tablets Famciclovir tablets/ Teva Nonsedating antihistamine Release * Zyrtec Approved 12/27/07 Early 2008 Cetirizine will be available OTC. Brand Zyrtec OTC products, marketed by Johnson & Johnson, became available in January 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 Attention deficit Focalin Early TBD TBD Patent litigation is ongoing. hyperactivity XR disorder Blood pressure Cardizem LA Early TBD TBD Andrx will not market until April 1, 2009, per agreement with Biovail. Antidepressant Lexapro Approved 02/06/07 TBD Patent litigation upheld. Patent expires in Cholesterol Vytorin Early TBD TBD Patent expires September Antiviral Famvir Approved 08/24/07 Court allowed Teva to resume marketing in late September Litigation ongoing. 4

5 Generic Therapeutic Class For Brand Fluticasone/ salmeterol powder for inhalation Fluvastatin capsules and fluvastatin tablets Formoterol powder for inhalation Granisetron tablets/ Barr Lansoprazole delayed-release capsules/teva Losartan tablets/lek Metoprolol tablets/kv Pharm and Sandoz Modafinil tablets/multiple Release * Antiasthmatic Advair Early TBD TBD Patent expires September Diskus Cholesterol Lescol and Lescol XL Early TBD TBD Patent expires April Antiasthmatic Foradil Early TBD TBD Patent expires December Aerolizer Anti-emetic Kytril Approved 12/28/07 January 2008 Patent expired December 28, Gastric acid Prevacid Late Tentative TBD Teva is currently in patent secretion reducer litigation concerning the generic, and a court decision is expected (angiotensin receptor blocker) (beta-blocker) before June Cozaar Late Tentative TBD Patent protection ends August Toprol XL Approved 05/18/07 Available Narcolepsy Provigil Late Tentative TBD Patent protection ends November

6 Generic Therapeutic Class For Brand Ofloxacin 0.3% otic solution/apotex Omeprazole delayed-release tablets/dexcel Pantoprazole delayed-release Paroxetine tablets/mylan Release * 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 January 30, 2008 and is currently involved in patent litigation with Wyeth. Antidepressant Paxil CR Approved 06/29/07 TBD Wyeth launched its generic Protonix, distributed by Prasco on January 29, 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. Protonix patent will expire in July 2010 but may be extended to January 2011 with pediatric exclusivity. 6

7 Generic Therapeutic Class For Brand Propranolol capsules/par Ramipril tablets/tbd Repaglinide tablets/ Caraco Risperidone tablets and solution/pliva Rivastigmine capsules/dr. Reddy s Laboratories (DRL) Rosiglitazone Rosiglitazone/me tformin Rosiglitazone/gli mepiride beta-blocker Release * Inderal LA Approved 01/26/07 02/02/07 Altace Approved 10/24/200 01/09/08 Generic ramipril was launched by ACE-inhibitor 5 Cobalt. Antidiabetic Prandin Late Tentative TBD Antipsychotic Risperdal Late Tentative TBD Pediatric exclusivity expires June Alzheimer s Exelon Approved 10/31/07 Launch suspended until Antidiabetic Avandia Early Tentative TBD Under the settlement reached between Teva and GlaxoSmithKline, Teva is allowed to launch the generic in the first quarter of Antidiabetic Avandamet Early Tentative TBD Under the settlement reached between Teva and GlaxoSmithKline, Teva is allowed to launch the generic in the first quarter of 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

8 Generic Therapeutic Class For Brand Rosuvastatin tablets Salmeterol powder for inhalation Sildenafil Sumatriptan injection and tablets/multiple Terbinafine tablets and topical cream/multiple Valacyclovir tablets/ranbaxy Valsartan tablets/ranbaxy Venlafaxine capsules/sun Pharmaceuticals Zaleplon capsules/ multiple Zolpidem tablets/ranbaxy Release * Cholesterol Crestor Early TBD TBD Patent expires January Antiasthmatic Serevent Early TBD TBD Patent expires September Diskus Erectile dysfunction Viagra Late Tentative TBD Migraine Imitrex Late Tentative TBD Ranbaxy settled all matters with GlaxoSmithKline, and generic launch is anticipated in December Antifungal Lamisil Approved 7/2/07 7/10/07 Antiviral Valtrex Approved 01/31/07 TBD Litigation dismissed; product to be marketed late Diovan Late Tentative TBD Patent protection ends September angiotensin receptor blocker Antidepressant Effexor Early TBD TBD Sun Pharmaceuticals obtained XR Wyeth s permission, the innovator of Effexor XR, and will submit an abbreviated new drug application. Insomnia Sonata Mid Tentative TBD Anticipated availability in 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. 8

9 Information for Mortar & Pestle is obtained from the following sources (with secondary-source links provided): Food and Drug Administration ( American Society of Health-Systems Pharmacists ( P&T Community ( Pharmaceutical News Harvest ( Drugs.com ( Pharmacy OneSource ( 9