First-Time Generic Drug Approvals for 2008
January
- Cetirizine Hydrochloride Chewable Tablets 5 mg and 10 mg
Approved: January 11, 2008 Caraco Pharmaceutical Laboratories, Ltd.
Generic for: Zyrtec Allergy Tablets and Zyrtec Hives Relief - Technetium Tc-99m Mebrofenin Kit (Injection) 45 mg/vial
Approved: January 29, 2008 CIS-US, Inc.
Generic for: Choletec Kit For Injection - Dextroamphetamine Sulfate Oral Solution 5 mg/5 mL
Approved: January 29, 2008 Outlook Pharmaceuticals, Inc.
Generic for: Dexedrine Oral Solution (Elixir) - Calcium Acetate Tablets USP, 667 mg
Approved: January 30, 2008 Roxane Laboratories, Inc.
Generic for: Phoslo Tablets, 667 mg
February
- Cefuroxime Axetil for Oral Solution USP 125 mg/5 mL and 250 mg/5 mL
Approved: February 5, 2008 Ranbaxy Pharmaceuticals, Inc.
Generic for: Ceftin for Oral Suspension - Famotidine, Calcium Carbonate, Magnesium Hydroxide 10 mg/800 mg/165 mg Chewable Tablets
Approved: February 6, 2008 Perrigo R&D Company
Generic for: Pepcid Complete - Alendronate Sodium Tablets USP, 5 mg (base), 10 mg (base), and 40 mg (base) for Once-Daily Dosing; and 35 mg (base) and 70 mg (base) for Once-Weekly Dosing
Approved: February 6, 2008 Teva Pharmaceuticals USA; Barr Laboratories, Inc. (70 mg Once-Weekly only)
Generic for: Fosamax Tablets - Pramipexole Dihydrochloride Tablets 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 1.5 mg
Approved: February 19, 2008 Barr Laboratories, Inc.
Generic for: Mirapex Tablets - Irinotecan Hydrochloride Injection 20 mg/mL; packaged in 40 mg/2 mL and 100 mg/5 mL single-use vials
Approved: February 20, 2008 Watson Laboratories, Inc.
Generic for: Camptosar Injection - Cetirizine HCl and Pseudoephedrine HCl Extended-Release Tablets 5 mg/120 mg
Approved: February 25, 2008 Teva Pharmaceuticals USA
Generic for: Zyrtec-D Extended-Release Tablets - Calcium Acetate Capsules 667 mg (equivalent to 169 mg calcium)
Approved: February 26, 2008 Roxane Laboratories, Inc.
Generic for: Phoslo Gelcaps - Granisetron Hydrochloride Oral Solution 2 mg (base)/10 mL
Approved: February 28, 2008 Cypress Pharmaceutical, Inc.
Generic for: Kytril Oral Solution, 2 mg/10 mL
March
- Prednisolone Sodium Phosphate Oral Solution, 10 mg (base)/5 mL
Approved: March 7, 2008 Pharmaceutical Associates, Inc.
Generic for: Orapred Oral Solution - Clobetasol Propionate Foam 0.05%
Approved: March 10, 2008 Perrigo Israel Pharmaceuticals, Ltd.
Generic for: Olux Foam - Amifostine for Injection USP, 500 mg/vial
Approved: March 14, 2008 Sun Pharmaceutical Indistries, Ltd.
Generic for: Ethyol for Injection - Ciprofloxacin and Dextrose 5% Injection USP, 2 mg/mL; packaged in 200 mg/100 mL and 400 mg/200 mL Flexible Plastic Containers
Approved: March 18, 2008 Baxter Healthcare Corporation; ACS Dobfar Info S.A.; Claris Lifesciences Limited; Hospira, Inc.
Generic for: Cipro I.V. in Dextrose 5% Injection - Metronidazole Injection USP 5 mg/mL (100 mL containers)
Approved: March 31, 2008 Claris Lifescience Ltd.
Generic for: Flagyl I.V. RTU Injection, 500 mg/100 mL
April
- Cetirizine Hydrochloride Oral Solution 1 mg/mL (OTC)
Approved: April 9, 2008 Perrigo R&D Company
Generic for: Children's Zyrtec Allergy And Hives-Relief - Levalbuterol Hydrochloride Inhalation Solution 0.31 mg (base), 0.63 mg (base), and 1.25 mg (base); packaged in 3 mL Unit-Dose Vials
Approved: April 9, 2008 Breath Limited
Generic for: Xopenex Inhalation Solution - Fluorouracil Cream USP, 5%
Approved: April 11, 2008 Spear Pharmaceuticals, Inc.
Generic for: Efudex Topical Cream, 5% - Estradiol And Norethindrone Acetate Tablets 1 mg/0.5 mg
Approved: April 17, 2008 Breckenridge Pharmaceutical, Inc.
Generic for: Activella Tablets - Ribavirin Tablets 500 mg (New Strength)
Approved: April 18, 2008 Zydus Pharmaceuticals USA, Inc.
Generic for: Copegus Tablets - Epoprostenol Sodium for Injection 0.5 Mg (base)/vial and 1.5 mg (base)/vial
Approved: April 23, 2008 Teva Parenteral Medicines, Inc.
Generic for: Flolan for Injection - Donepezil Hydrochloride Tablets 5 mg and 10 mg
Approved: April 28, 2008 Teva Pharmaceuticals USA
Generic for: Aricept Tablets
May
- Ropinirole Hydrochloride Tablets 0.25 mg (base), 0.5 mg (base), 1 mg (base), 2 mg (base), 3 mg (base) and 4 mg (base)
Approved: May 5, 2008 Mylan Pharmaceuticals, Inc.; Roxane Laboratories, Inc.
Generic for: Requip Tablets - Calcipotriene Topical Solution 0.005% (Scalp Solution)
Approved: May 6, 2008 Nycomed US, Inc.
Generic for: Dovonex Scalp Solution, 0.005% - Acarbose Tablets 25 mg, 50 mg, and 100 mg
Approved: May 7, 2008 Roxane Laboratories, Inc.; Cobalt Laboratories
Generic for: Precose Tablets - Drospirenone and Ethinyl Estradiol Tablets 3 mg/0.03 mg; (28-day regimen)
Approved: May 9, 2008 Barr Laboratories, Inc.
Generic for: Yasmin Tablets - Fluoxetine Capsules USP 10 mg and 20 mg
Approved: May 20, 2008 Teva Pharmaceuticals USA
Generic for: Sarafem Pulvules - Cetirizine Hydrochloride Syrup 1 mg/mL (Rx only)
Approved: May 27, 2008 Teva Pharmaceuticals USA
Generic for: Zyrtec Syrup (Rx only) - Omeprazole Delayed-Release Capsules USP, 40 mg
Approved: May 30, 2008 Andrx Pharmaceuticals, LLC
Generic for: Prilosec Delayed-Release Capsules 40 mg
June
- Zaleplon Capsules 5 mg and 10 mg
Approved: June 6, 2008 Sandoz Inc.; Genpharm ULC; Unichem Laboratories Limited; Aurobindo Pharma Limited; Upsher-Smith Laboratories, Inc.; Teva Pharmaceuticals USA; Roxane Laboratories, Inc.
Generic for: Sonata Capsules - Prednisolone Sodium Phosphate Oral Solution 20 mg (base)/5 mL (new strength)
Approved: June 9, 2008 Pharmaceutical Associates, Inc.
Generic for: Orapred Oral Solution - Ciclopirox Gel 0.77%
Approved: June 10, 2008 Nycomed US, Inc.
Generic for: Loprox Gel - Torsemide Injection 10 mg/mL; 2 mL and 5 mL vials
Approved: June 10, 2008 Bedford Laboratories
Generic for: Demadex Injection, 10 mg/mL - Dronabinol Capsules USP, 2.5 mg, 5 mg, and 10 mg
Approved: June 27, 2008 Par Pharmaceutical, Inc.
Generic for: Marinol Capsules, 2.5 mg, 5 mg, 10 mg - Risperidone Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg
Approved: June 30, 2008 Teva Pharmaceuticals USA
Generic for: Risperdal Tablets
July
- Indomethacin for Injection USP 1 mg/vial
Approved: July 16, 2008 Bedford Laboratories
Generic for: Indocin IV, 1 mg/Vial - Doxycycline for Oral Suspension USP, 25 mg/5 mL
Approved: July 16, 2008 IVAX Pharmaceuticals, Inc.
Generic for: Vibramycin for Oral Suspension, 25 mg/5 mL - Nisoldipine Extended Release Tablets 20 mg, 30 mg and 40 mg
Approved: July 25, 2008 Mylan Pharmaceuticals, Inc.
Generic for: Sular Extended-Release Tablets - Mycophenolate Mofetil Capsules 250 mg
Approved: July 29, 2008 Roxane Laboratories, Inc.
Generic for: Cellcept Capsules, 250 mg - Divalproex Sodium Delayed-Release Tablets USP, 125 mg, 250 mg and 500 mg (Valproic Acid Activity)
Approved: July 29, 2008 Dr. Reddy's Laboratories Limited; Sun Pharmaceutical Industries, Ltd.; Genpharm ULC; Upsher-Smith Laboratories, Inc.; Sandoz Inc.; Teva Pharmaceuticals USA; Lupin Limited
Generic for: Depakote Delayed-Release Tablets - Mycophenolate Mofetil Tablets 500 mg
Approved: July 29, 2008 Roxane Laboratories, Inc.
Generic for: Cellcept Tablets, 500 mg - Eplerenone Tablets 25 mg and 50 mg
Approved: July 30, 2008 Apotex, Inc.
Generic for: Inspra Tablets, 25 mg and 50 mg
August
- Galantamine Tablets USP 4 mg, 8 mg and 12 mg
Approved: August 28, 2008 Barr Laboratories, Inc.; Alphapharm Pty Ltd.
Generic for: Razadyne Tablets
September
- Galantamine Hydrobromide Extended-Release Capsules 8 mg, 16 mg and 24 mg
Approved: September 15, 2008 Barr Laboratories, Inc.
Generic for: Razadyne ER - Ketamine Hydrochloride Injection USP, 200 mg (base)/20 mL multiple-dose vials
Approved: September 30, 2008 Bioniche Pharma USA
Generic for: Ketalar Injection
October
- Dorzolamide HCl and Timolol Maleate Ophthalmic Solution 2% (base)/0.5% (base)
Approved: October 28, 2008 Hi-Tech Pharmacal Co., Inc.; Apotex Inc.
Generic for: Cosopt Ophthalmic Solution - Dorzolamide Hydrochloride Ophthalmic Solution 0.2% (base)
Approved: October 28, 2008 Apotex Inc.; Hi-Tech Pharmacal Company, Inc.
Generic for: Trusopt Ophthalmic Solution
November
- Rocuronium Bromide Injection 10 mg/mL packaged in 5 mL and 10 mL Multiple-Dose Vials
Approved: November 26, 2008 Hospira Inc.; Teva Parenteral Medicines, Inc.; Generamedix, Inc.
Generic for: Zemuron Injection - Methylergonovine Maleate Injection USP 0.2 mg/mL
Approved: November 24, 2008 Pharmaforce, Inc.
Generic for: Methergine - Budesonide Inhalation Suspension 0.25 mg/2 mL and 0.5 mg/2 mL; packaged in Unit-Dose Vials
Approved: November 18, 2008 IVAX Pharmaceuticals
Generic for: Pulmicort Respules Inhalation Suspension - Calcitonin-Salmon Nasal Spray 200 IU/Spray
Approved: November 17, 2008 Apotex, Inc.
Generic for: Miacalcin Nasal Spray - Levetiracetam Tablets 250 mg, 500 mg and 750 mg
Approved: November 3, 2008 Mylan Pharmaceuticals, Inc.
Generic for: Keppra Tablets
December
- Stavudine Capsules USP, 15 mg, 20 mg, 30 mg and 40 mg
Approved: December 29, 2008 Hetero Drugs Limited; Aurobindo Pharma Limited; Matrix Laboratories Limited
Generic for: Zerit Capsules - Stavudine for Oral Solution USP, 1 mg/mL; (200 mL upon reconstitution)
Approved: December 29, 2008 Aurobindo Pharma USA, Inc.
Generic for: Zerit for Oral Solution - Letrozole Tablets USP, 2.5 mg
Approved: December 24, 2008 Mylan Pharmaceuticals, Inc.
Generic for: Femara Tablets - Ibuprofen and Diphenhydramine Citrate Tablets (OTC), 200 mg/38 mg
Approved: December 22, 2008 Perrigo R&D Company
Generic for: Advil PM Tablets - Gemcitabine for Injection USP, 200 mg/single-use vial and 1 gram/single-use vial
Approved: December 18, 2008 Teva Parenteral Medicines, Inc.
Generic for: Gemzar for Injection - Acetazolamide Extended Release Capsules 500 mg
Approved: December 10, 2008 Zydus Pharmaceuticals USA Inc.
Generic for: Diamox Capsules - Clobetasol Propionate Lotion 0.05%
Approved: December 4, 2008 Actavis Mid Atlantic LLC
Generic for: Clobex Topical Lotion