Medicolegal Issues

Market Watch


 

New Generics

  • Nateglinide (generic Starlix) tablets1

New Drugs, Indications, and Dosage Forms

  • Abatacept (Orencia), a selective costimulation modulator used in treating moderate to severe juvenile idiopathic arthritis and rheumatoid arthritis (RA), has undergone a label change regarding earlier use in methotrexate-naïve patients with moderate to severe RA of less than two years’ disease duration.2,3
  • Aliskiren/valsartan (Valturna) has been approved by the FDA for treating hypertension in patients with inadequate hypertension control using aliskiren or valsartan alone. It’s also approved for first-line treatment of patients who are likely to need multiple agents to manage their hypertension.4
  • Cethromycin (Restanza) has been granted orphan drug approval as a once-daily agent for the prophylaxis of anthrax, tularemia, and the plague. Studies are being conducted on the drug as a potential bioterrorism countermeasure agent through a Department of Defense contract.5
  • Ganciclovir ophthalmic gel 0.15% (Zirgan) has been approved by the FDA for treating acute herpetic keratitis. It held orphan drug status for this indication since April 2007. Comparable clinical resolution of herpetic keratitis was obtained compared with acyclovir at day seven in an open-label, multicenter study of 213 patients (77% ganciclovir; 72% acyclovir). The most common adverse effects in clinical trials were blurred vision, eye irritation, punctate keratitis, and conjunctival hyperemia. Dosing recommendations are to instill one drop of ganciclovir in the affected eye five times daily until the ulcer heals, then instill one drop three times daily for seven days. It is anticipated that this product will be available in a 5-g tube in early 2010.6
  • Glycerol phenylbutyrate (HPN-100), an experimental intermittent or chronic treatment for patients with cirrhosis and hepatic encephalopathy, has received orphan drug status. A phase-2 trial is planned for late 2009 or early 2010.7 Glycerol phenylbutyrate is a pre-pro-drug of phenylacetic acid, the active component of buphenyl (approved by the FDA to treat urea cycle disorders). Glycerol phenylbutyrate is administered in liquid form and also has orphan drug status for treating urea cycle disorders.
  • Guanfacine extended-release tablets (Intuiv), a once-daily, nonstimulant treatment for attention deficit hyperactivity disorder (ADHD), has been approved by the FDA for treating patients 6 to 17 years old. Because guanfacine is not a controlled substance, a 90-day supply can be prescribed.8
  • Pancrelipase (Zenpep), a delayed-release pancrelipase enzyme product, has been approved by the FDA for treating adults and children (ages 1 to 12) with cystic fibrosis. The most common adverse effects reported in clinical trials were flatulence, abdominal pain, headache, and cough. The product is available in four prescription strengths: “Eurand 5” is 5,000 USP units of lipase, 17,000 USP units of protease, and 27,000 USP units of amylase; “Eurand 10” is 10,000 units lipase, 34,000 units protease, and 55,000 units amylase; “Eurand 15” is 15,000 units lipase, 51,000 units protease, and 82,000 units amylase; and “Eurand 20” is 20,000 units lipase, 68,000 units protease, and 109,000 units amylase.9,10
  • Vigabatrin (Sabril) has been approved by the FDA in an oral solution as monotherapy for treating infantile spasms in children ages one month to 2 years. The tablets also are approved for adjunctive therapy for refractory complex partial seizures in adults who have not adequately responded to other treatments. It is available in 500-mg powder packets for oral solution preparation and 500-mg tablets.11 One severe adverse effect is progressive peripheral vision loss with the potential to decrease visual acuity. Due to this risk of permanent vision loss, vigabatrin is available only through a restricted distribution program.

Pipeline

  • Human papillomavirus quadrivalent (Types 6, 11, 16 and 18; Gardasil) has been recommended for approval to prevent genital warts in boys and young men 9 to 26 years old. The FDA is expected to make a decision by the end of 2009.12,13 This vaccine already is approved for use in men in 112 countries.
  • Oral insulin (Ora-Lyn) is a proprietary formulation that delivers insulin spray through the buccal mucosa.14 In September, Ora-Lyn was approved under the FDA’s Treatment Investigational New Drug (IND) program for both Type 1 and Type 2 diabetes mellitus. This program allows manufacturers to provide early medication access to investigational drugs for patients with life-threatening or other serious conditions for which there are no satisfactory treatment alternatives. Doctors must register with the IND program to obtain the medication for their patients.15Ora-Lyn already is approved abroad.

Drug Information

  • On Sept. 22, the FDA banned candy- and fruit-flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act. The goal is to reduce smoking in America.16 Menthol cigarettes and flavored tobacco products are not part of this ban, but they are being evaluated as many of these products are seen as a gateway for children and young adults to begin smoking. More information is available at www.fda.gov/flavoredtobacco. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

  1. Par Pharma to begin marketing Starlix generic. Pharmaceutical-Technology.com Web site. Available at: www.pharmaceutical-technology.com/news/news64185.html. Accessed Sept. 23, 2009.
  2. Highlights of prescribing information. FDA Web site. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2009/125118s0086lbl.pdf Accessed Sept. 23, 2009.
  3. Bratulic A. Bristol Myers Squibb: Orencia label updated to support earlier use in adults with RA. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=DA78CDE71605485C9BC1B3B40392B1C0&logRowId=323904. Accessed Sept. 23, 2009.
  4. Bratulic A. FDA approves Novartis’ Valturna for hypertension. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=4D45881D26B8447D950A4D63E80B806C&logRowId=327307. Accessed Sept. 23, 2009.
  5. Advanced Life Sciences’ Restanza could treat plague and anthrax. Pharmaceutical-Technology.com Web site. Available at: www.pharmaceutical-technology.com/News/News64553.html. Accessed Sept. 23, 2009.
  6. FDA approves Zirgan. Drugs.com Web site. Available at: www.drugs.com/newdrugs/sirion-therapeutics-announces-fda-approval-zirgan-ganciclovir-ophthalmic-gel-0-15-herpetic-keratitis-1657.html. Accessed Sept. 23, 2009.
  7. 7. Hyperion Therapeutics receives orphan drug designation for HPN-100 for the treatment of hepatic encephalopathy. Hyperion Therapeutics Web site. Available at: www.hyperiontx.com/press/release/pr_1253144476. Accessed Sept. 23, 2009.
  8. George J. FDA approves nonstimulant Shire ADHD drug. Philadelphia Business Journal Web site. Available at: philadelphia.bizjournals.com/philadelphia/stories/2009/08/31/daily40.html?surround=etf&ana=e_article. Accessed Sept. 23, 2009.
  9. Petrochko C. FDA approves first EPI drug for kids. Medpage Today Web site. Available at: www.medpagetoday.com/Gastroenterology/GeneralGastroenterology/15734. Accessed Sept. 23, 2009.
  10. Highlights of prescribing information. FDA Web site. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2009/022210s000lbl.pdf. Accessed Sept. 23, 2009.
  11. Sabril approved for infantile spasms and adult epileptic seizures. Monthly Prescribing Reference Web site. Available at: www.empr.com/Sabril-approved-for-infantile-spasms-and-adult-epileptic-seizures/article/147148/. Accessed Sept. 23, 2009.
  12. FDA advisory committee recommends approval for use of Gardasil in boys and men. Merck Web site. Available at: www.merck.com/newsroom/press_releases/product/2009_0909.html. Accessed Sept. 23, 2009.
  13. Bratulic A. Merck & Co.’s Gardasil recommended by FDA panel for use in boys and men. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=352E8E6109E14925B0168FF465E27C1F&logRowId=325991. Accessed Sept. 23, 2009.
  14. Generex technology. Generex Biotechnology Web site. Available at: www.generex.com/technology.php. Accessed Sept. 23, 2009.
  15. Reidy C. Generex Drug is OK’d under special FDA program. The Boston Globe Web site. www.generex.com/fckuploads/file/Boston_Globe_09_10_09.pdf. Accessed Sept. 23, 2009.
  16. Quinn K. Candy and fruit flavored cigarettes now illegal in United States; step is first under new tobacco law. Food and Drug Administration Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183211.htm. Accessed Sept. 23, 2009.

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