February Supplemental Approvals

Chart lists efficacy supplements and labeling supplements selected by the editors of Pharmaceutical Approvals Monthly. This is not a comprehensive list of all supplemental approvals.

Product & Sponsor	Change	Date Approved (Application No.)
Drug
Copegus Ribavirin Hoffman La-Roche Inc./Genentech Inc.	Concedes to sponsor’s appeal of an FDA-mandated labeling change to provide new safety information on the occurrence of the ribavirin-associated substitution NS5B_F415Y in hepatitis C genotype 1a subjects who fail combination HCV ribavirin-containing treatment regimens based on the fact there are no HCV NS5B polymerase inhibitors currently marketed; deletes a reference to ribavirin as a potential carcinogen	2/6/2013 (21-511/026)
Eligard Leuprolide Sanofi-Aventis U.S. LLC	Adds convulsions to post-marketing adverse reactions	2/27/2013 (21-343/027) (21-379/023) (21-488/025) (21-731/023)
Epiduo Adapalene/benzoyl peroxide Galderma Laboratories LP	Provides for treatment of acne vulgaris in patients 9-11 years of age	2/1/2013 (22-320/004)
Gleevec Imatinib Novartis Pharmaceuticals Corporation	Updates labeling to include occurrence of subdural hematoma in oncology patients	2/21/2013 (21-588/038)
Intelence Etravirine Janssen Research & Development LLC	Updates adult adverse reactions with information regarding the higher incidence of rash in women versus men; adds to the pediatric section safety information regarding the occurrence of rash; updates warnings with information regarding Drug Rash with Eosinophilia and Systemic Symptoms (DRESS)	2/27/2013 (22-187/12 & 14)
Jenloga/Kapvay Clonidine Shinogi Inc.	Adds a section to warnings and precautions pertaining to the risk of atrioventricular block and adds hallucinations to adverse reactions	2/12/2013 (22-331/012)
Lyrica Pregabalin P.F. Prism C.V./Pfizer Inc.	Extends to the oral solution the indication approved for the capsule formulation in June 2012 for management of neuropathic pain associated with spinal cord injury	2/28/2013 (22-488/007)
Niaspan Niacin AbbVie Inc.	Includes information from the AIM-HIGH clinical trial which found that adding Niaspan to statin therapy to reduce the risk of cardiovascular events in patients with well-controlled LDL cholesterol did not provide greater risk reduction	2/21/2013 (20-381/048)
Prezista Darunavir Janssen Products LP	Updates labeling with once-daily dosing in HIV-1 infected, treatment-naïve pediatric patients 3 to less than 12 years of age and HIV-1 infected treatment-experienced pediatric patients 3 to less than 18 years of age with no darunavir resistance associated substitutions, based on pediatric clinical trials TMC114-C230, TMC114-C212 and TMC114-228; adds once-daily dosing in HIV-1 infected treatment-naïve pediatric patients 12 to less than 18 years of age based on clinical study TMC114-C230, which evaluated once-daily dosing	2/1/2013 (21-976/028 & 029) (202-895/005 & 006)
Prinivil Lisinopril Merck Sharp & Dohme Corp.	Adds a precaution that dual blockade of the renin-angiotensin-aldosterone system with angiotensin receptor blockers, ACE inhibitors or direct renin inhibitors (such as aliskiren) is associated with increased risk of hypotension, syncope, hyperkalemia and changes in renal function (including acute renal failure) compared to monotherapy; adds contraindications for administering with aliskiren in patients with diabetes and to avoid use with aliskiren in patients with renal impairment	2/26/2013 (19-558/056)
Prinzide Lisinopril/hydrochlorothiazide Merck Sharp & Dohme Corp.	Adds a precaution that dual blockade of the renin-angiotensin-aldosterone system with angiotensin receptor blockers, ACE inhibitors or direct renin inhibitors (such as aliskiren) is associated with increased risk of hypotension, syncope, hyperkalemia and changes in renal function (including acute renal failure) compared to monotherapy; adds contraindications for administering with aliskiren in patients with diabetes and to avoid use with aliskiren in patients with renal impairment	2/26/2013 (19-778/049)
Pristiq Desvenlafaxine Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.	Adds data in support of an indication in adults for the maintenance treatment of major depressive disorder that also fulfills a post-marketing requirement	2/14/2013 (21-992/033)
Rebetol Ribavirin Merck Sharp & Dohme Corp.	Concedes to sponsor’s appeal of an FDA-mandated labeling change to provide new safety information on the occurrence of the ribavirin-associated substitution NS5B_F415Y in hepatitis C genotype 1a subjects who fail combination HCV ribavirin-containing treatment regimens based on the fact there are no HCV NS5B polymerase inhibitors currently marketed; deletes a reference to ribavirin as a potential carcinogen	2/6/2013 (20-903/050) (21-546/006)
Revlimid Lenalidomide Celgene Corporation	Eliminates the requirement for the MedGuide as an element of the REMS	2/8/2013 (21-880/029)
Rythmol Propafenone GlaxoSmithKline LLC	Adds a warning that Brugada syndrome may be unmasked after exposure and that an ECG should be performed after initiation of therapy	2/14/2013 (21-416/011)
Simcor Niacin/simvastatin AbbVie Inc.	Includes information from the AIM-HIGH clinical trial, which found that adding niacin to statin therapy to reduce the risk of cardiovascular events in patients with well-controlled LDL cholesterol did not provide greater risk reduction	2/21/2013 (22-078/015)
Stavzor Valproic acid Banner Pharmacaps Inc.	Retracts REMS while maintaining MedGuide as part of labeling; revises and strengthens language regarding use in women of childbearing potential to state that because of the risk to the fetus of neural tube defects and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless it is essential to the management of her medical condition; adds a note that evidence suggests that folic acid supplementation prior to conception and during the first trimester of pregnancy decreases the risk for congenital neural tube defects in the general population	2/26/2013 (22-152/003 & 004)
Thalomid Thalidomide Celgene Corporation	Eliminates the requirement for the MedGuide as an element of the REMS	2/8/2013 (20-785/048)
Tricor Fenofibrate AbbVie Inc.	Includes a warning based on the ACCORD trial, which failed to prove that adding fenofibrate to a statin would reduce the rate of cardiovascular disease events in patients with type 2 diabetes; warns of paradoxical decreases in HDL in patients taking fenofibrates; warns that cases of myopathy, including rhabdomyolysis, have been reported in patients taking fenofibrates co-administered with colchicine	2/5/2013 (21-656/023)
Victrelis Boceprevir Merck Sharp & Dohme Corporation	Expands the indication for treatment of chronic hepatitis C genotype 1 infections, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age or older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy to include prior null responders	2/13/2013 (202-258/003)
Vimpat Lacosamide UCB Inc.	Adds hallucination to post-marketing adverse reactions	2/5/2013 (22-255/008) (22-254/014) (22-253/021)
Zoloft Sertraline Pfizer Pharmaceuticals Inc.	Adds diabetes mellitus to post-marketing adverse reactions	2/1/2013 (19-839/079) (20-990/038)
Zortress Everolimus Novartis Pharmaceuticals Corporation	Adds a new indication for prophylaxis of allograft rejection in adult patients receiving a liver transplant	2/15/2013 (21-560/006)
Biologic
Lucentis Ranibizumab Genentech Inc.	Provides for a new dosing regimen for the treatment of neovascular (wet) age-related macular degeneration	2/6/2013 (125156/081)
Prolia/Xgeva Denosumab Amgen Inc.	Strengthens warnings to stress that denosumab can cause severe symptomatic hypocalcemia and fatal cases have been reported	2/15/2013 (125320/080)