Recent FDA Approvals

Labeling Updates

• K e y
• Boxed Warning
• Other Warnings^*
  *Warnings and Precautions; Adverse Reactions; Drug Interactions; and Contraindications
• Updates to Indications/Dosage
• Other Updates^†
  ^†Other labeling changes; added to PDR database

				Baraclude (entecavir)
				Benlysta (belimumab)
				Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate)
				D-Cal (calcium carbonate)
				Duac (benzoyl peroxide/clindamycin phosphate)
				Epivir-HBV (lamivudine)
				Fabior (tazarotene)
				Focalin XR (dexmethylphenidate hydrochloride)
				Fosamax (alendronate sodium)
				Ganirelix Acetate (ganirelix acetate)
				Halog Cream (halcinonide)
				Havrix (hepatitis A vaccine)
				Lunesta (eszopiclone)
				Mekinist (trametinib)
				Menhibrix (meningococcal groups C and Y and haemophilus b tetanus toxoid conjugate vaccine)
				NeoProfen (ibuprofen lysine)

				NuvaRing (ethinyl estradiol/etonogestrel)
				Orencia (abatacept)
				Pediarix (diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated poliovirus vaccine)
				PegIntron (peginterferon alfa-2b)
				Pregnyl (chorionic gonadotropin)
				Ranexa (ranolazine)
				Sovaldi (sofosbuvir) - RECENT FDA APPROVAL
				Tafinlar (dabrafenib)
				Truvada (emtricitabine/tenofovir disoproxil fumarate)
				Wellbutrin (bupropion hydrochloride)
				Wellbutrin SR (bupropion hydrochloride)
				Yervoy (ipilimumab)
				Zofran ODT Orally Disintegrating Tablets, Oral Solution, and Tablets (ondansetron, ondansetron hydrochloride)