Generic Drug Approvals

 
 

Generic Drug Approvals

  • First-Time Generic Approvals: Maxipime, Tessalon 200 mg, Vesanoid The FDA has approved generic formulations for cefepime hydrochloride 500 mg, 1-g, and 2-g base/vial for parenteral administration in the treatment of bacterial infections; benzonatate 200 mg for the treatment of cough; and tretinoin 10-mg capsules for the induction of remission in patients with acute promyelocytic leukemia (APL).
  • First-Time Generic Approvals: AccuNeb, Coreg, Famvir The FDA has approved first-time generic formulations for albuterol sulfate inhalation solution in the 0.021% (base) strength; carvedilol 3.125-, 6.25-, 12.5-, and 25-mg tablets; and famciclovir 125-, 250-, and 500-mg tablets.
  • First-Time Generic Approvals: Combunox, Dilantin, Antizol The FDA has approved first-time generic formulations for oxycodone hydrochloride and ibuprofen tablets in 5 mg/400 mg strength, extended phenytoin sodium capsules in 30-mg strength, and fomepizole injectable in 1 g/mL strength.
  • First-Time Generic Approvals: Procardia XL, Estrostep FE, Estrostep The FDA has approved first-time generic formulations for nifedipine extended-release tablets in 90-mg strength; norethindrone acetate and ethinyl estradiol tablets (28-day) in 1 mg/0.02 mg, 1 mg/0.03 mg, and 1 mg/0.035 mg strengths; and norethindrone acetate and ethinyl estradiol tablets (21-day) in 1 mg/0.02 mg, 1 mg/0.03 mg, and 1 mg/0.035 mg strengths.
  • First-Time Generic Approvals: Penlac, Tussionex Pennkinetic, Cerebyx The FDA has approved first-time generic formulations for ciclopirox topical solution (nail lacquer) 8%, hydrocodone polistirex and chlorpheniramine polistirex suspension in 5-mg/4-mg and 10-mg/8-mg strengths, and fosphenytoin sodium injection EQ 50 mg/mL strength.
  • First-Time Generic Approvals: Verelan PM, Cefotan, Nasarel The FDA has approved first-time generic formulations for verapamil hydrochloride 100-, 200-, and 300-mg extended-release capsules; cefotetan disodium injectable EQ 1 gm base/vial and EQ 2 gm base/vial; and flunisolide metered spray 0.029 mg/spray.
  • First-Time Generic Approvals: Dantrium, Lexapro Capsules, Protonix The FDA has approved first-time generic formulations for dantrolene sodium injectable 20 mg/vial; escitalopram oxalate capsules EQ 5-mg, 10-mg, and 20-mg base; and pantoprazole sodium delayed-release tablets EQ 20-mg and 40-mg base.
  • First-Time Generic Approvals: Paxil CR, Lamisil, Parlodel The FDA has approved first-time generic formulations for paroxetine hydrochloride extended release tablets 12.5 mg and 25 mg, terbinafine hydrochloride 250-mg tablets and terbinafine hydrochloride cream 1%, and bromocriptine mesylate capsules 5 mg.
  • First-Time Generic Approvals: Toprol-XL, Suprax, Lotrel The FDA has approved generic formulations for metoprolol succinate extended-release tablets for treatment of hypertension and other conditions, cefixime oral suspension for treatment of bacterial infections, and amlodipine besylate/benazepril for treatment of hypertension.
  • First-Time Generics: Ambien, Zoloft, Nimotop The FDA has approved generic formulations for zolpidem tartrate for treatment of insomnia, sertraline hydrochloride for treatment of depression, and nimodipine for improved neurological outcome following subarachnoid hemorrhage.
  • First-Time Generic Approvals: Corzide, Cipro XR, Cortef The FDA has approved first-time generic formulations for nadolol plus bendroflumethiazide 40-mg/5-mg and 80-mg/5-mg tablets (Corzide), ciprofloxacin 500- and 1000-mg extended-release tablets (Cipro XR), and hydrocortisone 5- and 10-mg tablets (Cortef).
  • First-Time Generic Approvals: Celexa, Videx, Dermatop The FDA has approved first-time generic formulations for citalopram HBr capsules (Celexa); didanosine pediatric powder for oral solution (Videx Pediatric Powder); and prednicarbate 0.1% ointment (Dermatop).
  • First-Time Generic Approvals: Aciphex, Zantac Syrup, Uniretic The FDA has approved first-time generic formulations for rabeprazole sodium delayed-release tablets (Aciphex), ranitidine oral solution/syrup (Zantac), and moexipril HCl plus hydrochlorothiazide tablets (Uniretic).
  • First-Time Generic Approvals: Paxil Suspension, Pamine, Mavik The FDA has approved first-time generic formulations for paroxetine HCl 10-mg/5-mL oral suspension (Paxil); methscopolamine bromide 2.5- and 5-mg tablets (Pamine and Pamine Forte); and trandolapril 1-, 2-, and 4-mg tablets (Mavik).
  • First-Time Generic Approvals: Oral Zofran, Wellbutrin XL, Kefzol Bulk The FDA has approved generic formulations for ondasetron HCl tablets and oral solution (Zofran); bupropion HCl extended-release tablets (Wellbutrin XL); and cefazolin sodium injection pharmacy bulk packages (Kefzol).
  • First-Time Generic Approvals: Ditropan XL, Zofran, Oxandrin The FDA has approved first-time generic formulations for oxybutynin chloride 5-, 10-, and 15-mg extended-release tablets (Ditropan XL); ondasetron HCl 2-mg/mL injection packaged in single and multidose vials (Zofran); premixed 0.64-mg/mL ondasetron injection with 5% dextrose in 50-mL flexible plastic containers (Zofran Injection Premixed); and oxandrolone 2.5- and 10-mg tablets (Oxandrin).
  • First-Time Generic Approvals: Klaron, MetroGel-Vaginal, Colestid The FDA has approved first-time generic formulations for sulfacetamide sodium 10% topical solution (Klaron), metronidazole 0.75% vaginal gel (MetroGel-Vaginal), and colestipol HCl 1-g tablets (Colestid).
  • First-Time Generic Approvals: Cafcit, Claritin Hives Relief Syrup, Dermatop The FDA has approved first-time generic formulations for caffeine citrate intravenous injection and oral solution (Cafcit); over-the-counter loratadine oral solution (Claritin Hives Relief Syrup); and prednicarbate 0.1% cream (Dermatop E Emollient).
  • First-Time Generic Approvals: Cipro IV, Surmontil, Lamictal The FDA has approved first-time generic versions of certain formulations of ciprofloxacin injection (Cipro IV); trimipramine maleate capsules (Surmontil); and lamotrigine tablets (Lamictal).
  • First-Time Generic Approvals: Climara, Toprol XL, Effexor The FDA has approved first-time generic formulations of an estradiol transdermal system (Climara), metoprolol succinate extended-release tablets (Toprol XL), and venlafaxine HCl tablets (Effexor).