Update
As a followup to the August “Market Watch,” pancrelipase (Creon) has been approved by the FDA and is available in three FDA-approved prescription strengths based on the lipase content (6,000, 12,000, and 24,000).18 TH
Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City.
References
- NDA submitted for acetavance, a treatment for acute pain and fever. Monthly Prescribing Reference Web site. Available at: www.empr.com/NDA-submitted-for-Acetavance-a-treatment-for-acute-pain-and-fever/article/136799/. Accessed July 8, 2009.
- AstraZeneca submits NDA for low dose aspirin/esomeprazole combination product. AstraZeneca Web site. Available at: www.astrazeneca-us.com/about-astrazeneca-us/newsroom/all/5762542?itemId=5762542. Accessed July 8, 2009.
- MonoSol Rx and Strativa Pharmaceuticals submit new drug application for ondansetron orally dissolving film strip. Available at: www.monosolrx.com/news_09/news_040909.html. Accessed July 8, 2009.
- Theratech shares jump 8 pct on FDA filing. Reuters Web site. Available at: www.reuters.com/article/idUSN0126728920090601. Accessed July 8, 2009.
- Impax receives FDA approval for generic precos tablets, 25 mg, 50 mg and 100 mg. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=67240&p=irol-newsArticle&ID=1289907&highlight=. Accessed July 8, 2009.
- Caraco: FDA approves generic prostate cancer drug. Forbes Web site. Available at: www.forbes.com/feeds/ap/2009/07/07/ap6626628.html. Accessed July 8, 2009.
- Walsh S. FDA approved coartem tablets to treat malaria. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149559.htm. Accessed July 8, 2009.
- Walsh S. FDA approves besivance to treat bacterial conjunctivitis. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm162486.htm. Accessed July 8, 2009.
- Ozurdex approved for treatment of macular edema. Monthly Prescribing Reference Web site. Available at: www.empr.com/Ozurdex-approved-for-treatment-of-macular-edema/article/138708/. Accessed July 8, 2009.
- Walsh S. FDA approves multaq to treat heart rhythm disorder. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170276.htm. Accessed July 21, 2009.
- Multaq label. FDA Web site: Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf. Accessed July 21, 2009.
- NuLev chewable melt tablets available again. Monthly Prescribing Reference Web site. Available at: www.empr.com/NuLev-Chewable-Melt-Tablets-available-again/article/138396/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed July 8, 2009.
- UCB’s Vimpat (lacosamide) approved by FDA as add-on therapy for partial onset seizures in adults. Epilepsy Foundation Web site. Available at: www.epilepsyfoundation.org/epilepsyusa/news/UCB_Vimpat.cfm. Accessed July 8, 2009.
- Bratulic A. FDA approves GlaxoSmithKline’s lamictal XR. Available at: www.firstwordplus.com/Fws.do?articleid=62DD8DEA3F594BDC98DA97F80AB13ABB&logRowId=307825. Accessed July 8, 2009.
- FDA approves ACTOplus met XR (pioglitazone HCL and metformin HCl extended-release) tablets for the treatment of Type 2 diabetes. Available at: www.pipelinereview.com/index.php/2009051326959/Small-Molecules/FDA-Approves-ACTOplus-met-XR-pioglitazone-HCl-and-metformin-HCl-extended-release-Tablets-for-the-Treatment-of-Type-2-Diabetes.html. Accessed July 8, 2009.
- FDA approval letter for risperdal consta. FDA Web site. Available at: www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021346s025,021346s028ltr.pdf. Accessed July 8, 2009.
- Todoruk M. United Therapeutics’ Adcirca approved for pulmonary arterial hypertension in US. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=E71E91953E9844D2A776B021E19AEE22&logRowId=306627. Accessed July 8, 2009.
- Creon delayed-release capsules available for exocrine pancreatic insufficiency. Monthly Prescribing Reference Web site. Available at: www.empr.com/Creon-delayed-release-capsules-available-for-exocrine-pancreatic-insufficiency/article/139668/. Accessed August 10, 2009.