March 2010 Supplements

Chart lists efficacy supplements and labeling supplements selected by the editors of "Pharmaceuticals Approvals Monthly."This is not a comprehensive list of all supplemental approvals.
Product	Sponsor	Change	Date Approved (Application No.)
Drug
Arixtra Fondaparinux	GlaxoSmithKline	Revises warnings and special populations to incorporate a statement that pediatric patients may be at increased risk of bleeding based on increased bleeding risk in adult patients who weigh less than 50 kg compared to patients with higher weights	3/26/2010 (21-345/023)
Cardura XL Doxazosin	Pfizer	Revises precautions to describe the additive blood pressure lowering effects and symptomatic hypotension that can result when administered concomitantly with phosphodiesterase-5 therapy	3/16/2010 (21-269/011)
Copegus Ribavirin	Roche	Revises postmarketing experience to add that pure red cell aplasia has been reported when used in combination with Pegasys (Roche's peginterferon alfa-2a)	3/3/2010 (21-511/018)
Emend Aprepitant	Merck	Updates label with data from postmarketing study 130 showing a higher proportion of patients had no vomiting after chemotherapy compared to placebo across measures of time and tumor type	3/19/2010 (21-549/017)
Femara Letrozole	Novartis	Provides additional clinical data regarding distant disease-free survival for the indication of adjuvant treatment of postmenopausal, hormone receptor positive, early breast cancer approved under accelerated approval; provides longer term safety and efficacy data for extended adjuvant treatment of early breast cancer in post-menopausal women after five years of adjuvant tamoxifen approved under accelerated approval	3/2/2010 (20-726/015 & 016)
Fosamax Alendronate	Merck	Revises dental precautions related to osteonecrosis of the jaw, specifically including invasive dental procedures as a known risk factor and noting discontinuation of bisphosphonate treatment may reduce the risk for ONJ in patients requiring such procedures; expands warning regarding use of bisphosphonates in patients with upper gastrointestinal problems to note caution should be used because of potential for worsening the underlying disease; adds low-energy femoral shaft and subtrochanteric fractures to post-marketing adverse reactions	3/1/2010 (20-560/051, 055 & 057) (21-575/012, 016 & 018)
Invega Paliperidone	Ortho McNeil Janssen	Adds 28 new adverse reactions identified in clinical studies or based on spontaneous reports	3/3/2010 (21-999/018)
Isoptin SR Verapamil	Ranbaxy	Updates precautions to note that sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with concurrent use with clonidine	3/31/2010 (19-152/033)
Kapidex Dexlansoprazole	Takeda	Approves a proprietary name change from Kapidex, which can be confused with AstraZeneca's cancer drug Casodex and Actavis' opioid analgesic Cadian, to Dexilant starting in late April	3/19/2010 (22-287/003)
MultiHance Gadobenate dimeglumine	Bracco	Alters patient population to include children over 2 years of age	3/17/2010 (21-357/006)
Patanase Olopatadine	Alcon	Revises clinical studies information to report that in two of three adult trials and one pediatric trial patients had significantly greater decreases in reflective symptom scores for itchy eyes and watery eyes compared to vehicle nasal spray	3/31/2010 (21-861/008)
Pepcid Famotidine	Merck	Adds hepatitis to adverse reactions	3/23/2010 (19-462/035)
Promacta Eltrombopag	GlaxoSmithKline	Modifies the approved REMS with administrative changes and adds information about blood clots to the Medication Guide; deletes dear customer letter from the elements to assure safe use since the letters have been distributed	3/5/2010 (22-291/003)
Propecia Finasteride	Merck	Revises precautions to note data from studies with Proscar (finasteride for symptomatic benign prostatic hyperplasia) showing it may decrease PSA levels and that any confirmed increases in PSA levels from nadir may signal the presence of prostate cancer and should be carefully evaluated even if they are within the normal range for men not taking a 5-alfa-reductase inhibitor	3/24/2010 (20-788/015)
Proscar Finasteride	Merck	Revises precautions to note that it may decrease PSA levels and that any confirmed increases in PSA levels from nadir may signal the presence of prostate cancer and should be carefully evaluated even if they are within the normal range for men not taking a 5-alfa-reductase inhibitor	3/23/2010 (20-180/033)
Rapaflo Silodosin	Watson	Revises warnings and precautions to describe the additive blood pressure lowering effects and symptomatic hypotension that can result when administered concomitantly with phosphodiesterase-5 therapy	3/4/2010 (22-206/006)
Skelid Tiludronate	Sanofi-Aventis	Provides bisphosphonate class labeling changes to warnings, with additional information regarding upper gastrointestinal adverse events; notes contraindication in patients who are unable to stand or sit upright for at least 30 minutes and adds to dosing that patients should not lie down for at least 30 minutes after taking the medication	3/19/2010 (20-707/006)
Tasigna Nilotinib	Novartis	Revises risk management plan to become a REMS with Medication Guide, communication plan and timetable for assessments of the REMS in response to new safety information concerning cases of QT prolongation	3/15/2010 (22-068/001)
Toprol-XL Metoprolol	AstraZeneca	Adds to warnings that initiation of high-dose extended release metoprolol should be avoided in patients undergoing non-cardiac surgery because of cardiovascular risk; adds to clinical trials experience that in a controlled trial of 8,351 patients with or at risk for atherosclerotic disease undergoing non-vascular surgery and not taking beta-blocker therapy, use was associated with a higher incidence of bradycardia, hypotension, stroke and death compared to placebo	3/19/2010 (19-962/041)
Tyzeka Telbivudine	Novartis	Adds warning based on postmarketing events that cases of myopathy/myositis have been reported several weeks to months after starting therapy, as with some other drugs in the class; rhabdomyolysis and uncomplicated myalgia also have been reported	3/4/2010 (22-011/003) (22-154/001)
Verelan Verapamil	Elan	Adds to precautions that hypotension, bradyarrhythmias and lactic acidosis have been observed in patients receiving ketolide antibiotic telithromycin concurrently, and that sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with concurrent use with clonidine	3/30/2010 (19-614/045)
Viread Tenofovir	Gilead	Expands indication to include treatment of HIV infection in combination with other antiretroviral agents in patients 12 to less than 18 years of age based on 48-week clinical data from study GS-US-104-0321 in treatment-experienced adolescents, which failed to show a difference in virologic response between treatment and placebo, but the comparability of the pharmacokinetic and safety data to adult data supports use in patients 12 or older; adds to warnings and precautions that assessment of bone mineral density should be considered for adults and adolescents who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss	3/24/2010 (21-356/033)
Vivitrol Naltrexone	Alkermes	Adds language regarding risk of serious injection site reactions likely caused by incorrect administration of the drug and a REMS with Medication Guide and timetable for submission of assessments of the REMS	3/22/2010 (21-897/005 & 010)
Vytorin Ezetimibe/simvastatin	Merck	Revises warnings and precautions to note that Chinese patients should not receive Vytorin 10/80 mg because of a dose-related risk for myopathy when the statin is coadministered with lipid-modifying doses of niacin-containing products; cases of myopathy/rhabdomyolysis have been observed with simvastatin coadministered with lipid-modifying doses of niacin-containing products, with a higher incidence of myopathy in Chinese patients	3/10/2010 (21-687/034)
Zocor Simvastatin	Merck	Revises warnings and precautions to note that because of increased risk for myopathy, caution should be used when the statin is coadministered with lipid-modifying doses of niacin-containing products to Chinese patients; notes cases of myopathy/rhabdomyolysis have been observed with simvastatin coadministered with lipid-modifying doses of niacin-containing products	3/2/2010 (19-766/078)
Biological
Botox/Botox Cosmetic OnabotulinumtoxinA	Allergan	Injectable acetylcholine release inhibitor/neuromuscular blocking agent approved to treat spasticity in the flexor muscles of the elbow, wrist and fingers in adults; updates the existing Medication Guide and REMS	3/9/2010 (103000/5189)
Neupogen Filgrastim	Amgen	Updates precautions to include information regarding a voluntary pregnancy surveillance program	3/2/2010 (103353/5127)
Pegasys Peginterferon alfa-2a	Roche	Revises postmarketing experience to add that pure red cell aplasia has been reported with Pegasys alone and in combination with Copegus (Roche's branded ribovirin)	3/3/2010 (103964/5177)