| 12 Apr 2007 |
Altabax (topical ointment) |
Retapamulin |
Glaxo Group |
For topical treatment of impetigo due to Staphylococcus aureus (methicillin susceptible) or Streptococcus pyogenes in adults and pediatric patients aged 9 mo or older (up to 100 cm2 in total area in adults or 2% total body surface area in children ≥9 mo) |
| 27 Apr 2007 |
AzaSite (ophthalmic solution/drops) |
Azithromycin |
Inspire Pharmaceuticals |
For treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms: CDC coryneform group G, H. influenzae, Staphylococcus aureus, Streptococcus mitis group, and Streptococcus pneumoniae |
| 21 May 2007 |
Tindamax (tablet) |
Tinidazole |
Mission Pharma |
Indications expanded to include treatment of bacterial vaginosis in nonpregnant women |
| 18 June 2007 |
Lexiva (tablet, oral suspension) |
Fosamprenavir calcium |
GlaxoSmithKline |
Indications expanded to include children ≥2 yr of age, in combination with other antiretroviral agents for treatment of HIV-1 infection |
| 6 Aug 2007 |
Selzentry (tablet) |
Maraviroc |
ViiV Healthcare |
In combination with other antiretroviral drugs, for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable virus who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents |
| 14 Sep 2007 |
Levaquin (tablet, oral solution, injection) |
Levofloxacin |
Ortho-McNeil Pharmaceuticals |
Indications expanded to include complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa and acute pyelonephritis caused by E. coli, including cases with concurrent bacteremia |
| 28 Sep 2007 |
Lamsil (oral granules) |
Terbinafine hydrochloride |
Novartis |
For treatment of tinea capitis in patients 4 yr of age or older |
| 12 Oct 2007 |
Doribax (injectable) |
Doripenem |
Ortho-McNeil Janssen |
For treatment of complicated intra-abdominal infections caused by E. coli, K. pneumoniae, P. aeruginosa, Bacteroides caccae, Bacteroides fragilis, Bacteriodes thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Streptococcus intermedius, Streptococcus constellatus, and Peptostreptococcus micros and for treatment of complicated urinary tract infections, including pyelonephritis caused by E. coli, including cases with concurrent bacteremia, K. pneumoniae, P. mirabilis, P. aeruginosa, and Acinetobacter baumannii |
| 12 Oct 2007 |
Isentress (tablet) |
Raltegravir potassium |
Merck Sharp & Dohme |
For treatment of HIV-1 infection in treatment-experienced adult patients, in combination with other antiretroviral agents |
| 19 Dec 2007 |
Hepsera (tablets) |
Adefovir dipivoxil |
Gilead Sciences |
Indications expanded to include patients 12 yr of age or older for treatment of chronic hepatitis B with evidence of active viral replication and either evidence of persistent elevations in alanine aminotransferase or aspartate transaminase or histologically active disease |
| 18 Jan 2008 |
Intelence (tablet) |
Etravirine |
Tibotec |
For treatment, in combination with other antiretroviral agents, of HIV-1 infection in antiretroviral treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to a nonnucleoside reverse transcriptase inhibitor and other antiretroviral agents |
| 22 Jan 2008 |
Mycamine (infusion) |
Micafungin |
Astellas |
Indications expanded to include treatment of patients with candidemia, acute disseminated candidiasis, Candida peritonitis, and abscesses |
| 23 Jan 2008 |
Moxatag (extended-release tablet) |
Amoxicillin (extended release) |
MiddleBrook Pharmaceuticals |
For treatment of tonsillitis and/or pharyngitis caused by Streptococcus pyogenes in adults and pediatric patients 12 yr of age or older |
| 25 Mar 2008 |
Reyataz (capsule) |
Atazanavir sulfate |
Bristol-Myers Squibb |
Use extended to include pediatric patients at least 6 yr of age |
| 5 May 2008 |
Levaquin (tablet, oral solution, injection) |
Levofloxacin |
Ortho-McNeil Janssen |
Use extended to include pediatric patients at least 6 mo of age, after exposure to inhalational anthrax to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis |
| 20 Jun 2008 |
Kaletra (tablet, oral solution) |
Lopinavir and ritonavir |
Abbott Laboratories |
Use extended to include pediatric patients at least 14 days of age |
| 23 Jun 2008 |
Aptivus (capsule, oral solution) |
Tipranavir |
Boehringer-Ingelheim Pharmaceuticals |
Coadministered with ritonavir, use extended to treatment of HIV-1-infected pediatric patients (aged 2 to 18 yr) who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor, in combination with antiretroviral regimens |
| 24 Jun 2008 |
Viramune (tablet, oral suspension) |
Nevirapine |
Boehringer-Ingelheim Pharmaceuticals |
Dosing recommendations extended for pediatric patients at least 15 days of age |
| 29 Jul 2008 |
Cancidas (injection) |
Caspofungin acetate |
Merck Research Laboratories |
Use extended to include pediatric population ≥3 mo to 16 yr of age |
| 11 Aug 2008 |
Viread (tablet) |
Tenofovir disoproxil fumarate |
Gilead Sciences |
New indication: for the treatment of chronic hepatitis B infection in adults |
| 3 Sep 2008 |
Valtrex (caplet) |
Valacyclovir hydrochloride |
GlaxoSmithKline |
Use extended to treatment of chickenpox in immunocompetent pediatric patients 2 to <18 yr of age |
| 7 Oct 2008 |
Zmax (powder for oral suspension) |
Azithromycin extended release |
Pfizer |
Use extended to pediatric patients 6 mo or older for treatment of community-acquired pneumonia caused by Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or S. pneumoniae in patients appropriate for oral therapy |
| 21 Oct 2008 |
Prezista (tablet) |
Darunavir ethanolate |
Centocor Ortho |
Use expanded to include, in combination with ritonavir and other antiretroviral agents, the treatment of HIV-1 in antiretroviral treatment-naïve adults |
| 11 Dec 2008 |
PegIntron |
Peginterferon alfa-2B |
Schering |
Use extended to include PegIntron in combination with Rebetol (ribavirin) for treatment of chronic hepatitis C in patients ≥3 yr of age with compensated liver disease previously untreated with alpha interferon |
| 18 Dec 2008 |
Prezista (tablet) |
Darunavir ethanolate |
Centocor Ortho |
Use extended to include, in combination with ritonavir and other antiretroviral agents, the treatment of HIV-1 infection in pediatric patients ≥6 yr of age |
| 2 Feb 2009 |
Combivir (tablet) |
Zidovudine and lamivudine |
ViiV Healthcare |
Allows for the use of the combination tablet in children weighing ≥30 kg, in combination with other antiretrovirals for treatment of HIV-1 infection |
| 20 Mar 2009 |
Tygacil (injection) |
Tigecycline |
Wyeth Pharmaceuticals |
Indications expanded to include treatment of community-acquired bacterial pneumonia caused by S. pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, H. influenzae (β-lactamase-negative isolates), and L. pneumophila; list of indicated organisms also expanded for the indications approved earlier |
| 7 Apr 2009 |
Coartem (tablet) |
Artemether and lumefantrine |
Novartis |
For treatment of acute, uncomplicated malaria due to Plasmodium falciparum in patients ≥5 kg body weight |
| 28 May 2009 |
Besivance (ophthalmic suspension) |
Besifloxacin hydrochloride |
Bausch & Lomb |
For treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: CDC coryneform group G, Corynebacterium pseudodiphtheriticum, Corynebacterium striatum, H. influenzae, Moraxella lacunata, S. aureus, Staphylococcus epidermidis, Staphylococcus hominis, Staphylococcus lugdunensis, S. mitis group, Streptococcus oralis, S. pneumoniae, and Streptococcus salivarius |
| 8 Jul 2009 |
Isentress (tablet) |
Raltegravir |
Merck |
Use expanded to include treatment-naïve (in addition to treatment-experienced) individuals, in combination with other antiretrovirals, for treatment of adults with HIV-1 infection |
| 31 Jul 2009 |
Xerese (topical cream) |
Acyclovir and hydrocortisone |
Medivir |
For early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative sores and to shorten lesion healing time in adults and adolescents ≥12 yr old (information from the label of 12 May 2010) |
| 28 Aug 2009 |
Valcyte (tablet, powder for oral solution) |
Valganciclovir hydrochloride |
Roche Palo Alto |
For prevention of cytomegalovirus disease in pediatric kidney and heart transplant patients ≥4 mo of age at high risk of such disease |
| 11 Sep 2009 |
Vibativ (for injection) |
Telavancin hydrochloride |
Theravance |
For treatment of adult patients with complicated skin and skin structure infections caused by susceptible isolates of the following: S. aureus (including methicillin-susceptible and -resistant isolates), S. pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), or E. faecalis (vancomycin-susceptible only) |
| 15 Sep 2009 |
Zirgan (ophthalmic gel) |
Ganciclovir |
Sirion Therapeutics |
For treatment of acute herpetic keratitis (dendritic ulcers) |