Generic Drug Approvals

 
 
  • First-Time Generic Approvals: Mobic, Propecia, Zithromax The FDA has approved first-time generic formulations for meloxicam 7.5- and 15-mg tablets (Mobic), finasteride 1-mg tablets (Propecia), and azithromycin 100-mg/5-mL and 200-mg/5-mL oral suspension (Zithromax).
  • First-Time Generic Approvals: Zoloft, Urocit-K, Parnate The FDA has approved first-time generic formulations for sertraline HCl 25-, 50-, and 100-mg tablets (Zoloft); potassium citrate 5- and 10-mEq extended-release tablets (Urocit-K); and tranylcypromine sulfate 10-mg tablets (Parnate).
  • First-Time Generic Approvals: Zocor and Lamictal Chewables The FDA has approved first-time generic formulations for simvastatin 5-, 10-, 20-, 40-, and 80-mg tablets (Zocor) and lamotrigine 5- and 10-mg chewable tablets (Lamictal).
  • First-Time Generic Approvals: Proscar, Omnicef, Zaditor The FDA has approved first-time generic formulations for finasteride 5-mg tablets (Proscar), cefdinir 125-mg/5-mL oral suspension (Omnicef), and ketotifen fumarate 0.025% ophthalmic solution (Zaditor).
  • First-Time Generic Approvals: Novantrone, Terazol 3, Norco The FDA has approved first-time generic formulations for mitoxantrone HCl 2-mg/mL injection (Novantrone), terconazole 80-mg vaginal suppositories (Terazol 3), and a new 7.5-mg/300-mg strength of hydrocodone bitartrate plus acetaminophen tablets (Norco).
  • First-Time Generic Approvals: Glucotrol XL, Retrovir, Salagen The FDA has approved first-time generic formulations for glipizide 2.5-mg extended-release tablets (Glucotrol XL), zidovudine 100-mg capsules (Retrovir), and pilocarpine HCl 7.5-mg tablets (Salagen).
  • First-Time Generic Approvals: Flonase and Zantac The FDA has approved first-time generic formulations for fluticasone propionate 50-µg nasal spray (Flonase) and ranitidine HCl 25-mg/mL injection in 6- and 40-mL vials (Zantac).
  • First-Time Generic Approvals: Flexeril, Plavix, and AndroGel The FDA has approved first-time generic formulations for cyclobenzaprine HCl 5-mg tablets (Flexeril), clopidogrel bisulfate 75-mg tablets (Plavix), and testosterone 1% gel (AndroGel).
  • First-Time Generic Approvals: Commit, Dynacirc, Norco The FDA has approved first-time generic formulations for nicotine polacrilex 2- and 4-mg lozenges (Commit); isradipine 2.5- and 5-mg capsules (Dynacirc); and hydrocodone bitartrate plus acetaminophen 5-mg/300-mg tablets (Norco).
  • First-Time Generic Approvals: Xanax XR, Dostinex, Percocet The FDA has approved first-time generic formulations for alprazolam 0.5-mg extended-release tablets (Xanax XR); cabergoline 0.5-mg tablets (Dostinex); and oxycodone HCl/acetaminophen 2.5/300-mg, 5/300-mg, 7.5/300-mg, and 10/300-mg tablets (Percocet).
  • First-Time Generic Approvals: Zithromax, Cefzil, Zonegran The FDA has approved first-time generic formulations for azithromycin 500-mg/vial (Zithromax); cefprozil 125-mg/5-mL and 250-mg/5-mL suspension (Cefzil); and zonisamide 25-, 50-, and 100-mg capsules (Zonegran).
  • First-Time Generic Approvals: Copegus, Tegretol, Roxicodone The FDA has approved first-time generic formulations for ribavirin (Copegus), carbamazepine (Tegretol), and oxycodone HCl (Roxicodone).
  • First-Time Generic Approvals: Phenergan Tablets, Floxin Otic, Sodium... The FDA has approved first-time generic formulations for promethazine HCl 12.5-, 25-, and 50-mg tablets (Phenergan); ofloxacin 0.3% otic solution (Floxin); and sodium bicarbonate 7.5% (0.9-mEq/mL) and 8.4% (1-mEq/mL) injection in prefilled 50-mL syringes.
  • First-Time Generic Approvals: Dilaudid, Cefzil, Zithromax The FDA has approved first-time generic formulations for hydromorphone HCl 2-, 4-, and 8-mg tablets (Dilaudid); cefprozil 250- and 500-mg tablets (Cefzil); and azithromycin 250-, 500-, and 600-mg tablets (Zithromax).
  • First-Time Generic Approvals: Metaglip, Zofran ODT, Floxin Otic The FDA has approved first-time generic formulations for glipizide/metformin HCl 2.5-mg/250-mg, 2.5-mg/500-mg, and 5-mg/500-mg tablets (Metaglip), ondansetron 4- and 8-mg orally disintegrating tablets (Zofran ODT), and ofloxacin 0.3% otic solution (Floxin Otic).
  • First-Time Generic Approvals: Amaryl, Norvasc, Altace The FDA has approved first-time generic formulations for glimepiride tablets (Amaryl); amlodipine besylate tablets (Norvasc); and ramipril capsules (Altace).
  • First-Time Generic Approvals: Arava, Renova, Retrovir The FDA has approved first-time generic formulations for leflunomide 10- and 20-mg tablets (Arava), 0.05% tretinoin emollient cream (Renova), and zidovudine 50-mg/5-mL oral solution and 300-mg tablets (Retrovir).
  • First-Time Generic Approvals: Triostat, Rocephin, Allegra The FDA has approved first-time generic formulations for 10 mcg [base]/mL liothyronine sodium injection in 1-mL vials (Triostat); 1 g/50 mL and 2 g/50 mL ceftriaxone injection packaged in galaxy single-dose plastic containers (Rocephin), and 30, 60, and 180 mg fexofenadine HCl tablets (Allegra).
  • First-Time Generic Approvals: Rifamate Capsules, Locoid Ointment, Klonopin The FDA has approved first-time generic formulations of rifampin plus isoniazid 300-mg/150-mg capsules (Rifamate), hydrocortisone butyrate 0.1% ointment (Locoid), and clonazepam orally disintegrating tablets (Klonopin).
  • First-Time Generic Approvals: New Doses of Tapazole, Monodox, Mestinon The FDA has approved first-time generic formulations and dosage strengths of 15-mg methimazole tablets USP (Tapazole), 150-mg doxycycline monohydrate tablets (Monodox), and 30-mg pyridostigmine bromide tablets, USP (Mestinon).