Appendix-I List of Recently Approved New Drugs and Combinations 463 …Contd 149 Reboxetine 150 Cefprozil 151 Cilostazol 152 Escitalopram oxalate 153 Anastrazole 154 Rizapriptan 155 Gadobenate (Dimeglumine IV injection) 156 Tacrolimus ointment 157 Metolazone 158 Tiotropium bromide 159 Gadoversetamide inj 160 Torsamide 161 Cyproterone 162 Aripiprazole 163 Azelaic acid 164 Bendrofluazide 165 Vinpocetin 166 Tirofiban hydrochloride IV 167 Teriparatide 168 Cladribine 169 Tadalafil 170 S-Atenolol 171 Rosuvastatin 172 Tazarotene 173 Aceclofenac 174 Ibopamine hydrochloride 175 Trandolapril 176 Dorzolamide 177 Fenoverine 178 Risedronate sodium 179 Fondaparinax sodium 180 Metadoxine 181 Valgancyclovir 182 Isopropyl Unoprostone 183 Amorolfine 184 Fluvastatin sodium 185 Modafinil 186 Sufentanil citrate 187 Ezetimibe 188 Dutasteride 189 Gefitinib Antidepressant Antibiotic For intermittent claudication Antidepressant Anticancer Antimigraine MRI contrast medium Immunomodulator Diuretic Antiasthmatic MRI contrast medium Diuretic For prostatic cancer Anti schizophrenia Antiacne Diuretic Antipsychotic Antiplatelet For Osteoporosis Anticancer For erectile dysfunction Antihypertensive Lipid lowering agent Antiacne NSAID Ophthalmic Antihypertensive Ophthalmic Antispasmodic For osteoporosis LMWH (Low Molecular Weight Heparin) For hepatic disorder For CMV (Cyto Megalo virus) Ophthalmic Antifungal Lipid lowering agent For sleeping disorder Anaesthetic agent Lipid lowering agent For BPH Anti-cancer Contd.… Appendices 464 …Contd 190 Imidapril 191 Adefovir Dipivoxil 192 Etoricoxib 193 Dicerein 194 Nitazoxanide 195 Trolamine cream (0.67%) 196 Neotame 197 Oxybutynine 198 Cabergoline 199 Rabeprazole Sodium Injection 200 Alfuzosin E.R 201 Tiagabine HCl 202 Racecadotril Sachet 203 Ibandronic Acid Inj 204 Tacrolimus Capsule 205 Cefdinir Dispersible 206 Linezolid 207 Cefprozil Dispersible tablet 208 Divalproex Sodium E.R tablets 209 Lithium Carbonate ER tablet 210 Nimesulide Injection 211 Levosalbutamol Tablet & Syrup 212 Memantine HCl 213 Pimcrolimus cream 214 Rebamipide 215 Cefetamet Pivoxil Suspension 216 Diclofenac Transdermal patch 217 Fluconazole Gel 218 Miglitol 219 Citicholine Tablet & Injection 220 Lamotrigine S.R tablet 221 Moxifloxacin Eye drops 222 Risperidone long-acting suspension for injection 223 Everolimus 224 Gemcitabine 225 b-arteether Injection 226 Ziprasidone powder for injection 227 Voriconazole Tablet & Infusion 228 Cefuroxime Axetil ER tablets Anti-hypertensive Anti-viral (Hepatitis-B) NSAID For osteoarthritis Anti-diarrhoeal For topical use Sweetening Agent For neurogenic bladder disorder For parkinson’s disease For gastric and Deudonal Ulcers & GERD For BPH Anti-epileptic Anti-diarrhoeal Anti-cancer For organ rejection Antibiotic For osteomyelitis in adults Antibiotic Anti-epileptic Anti-depressant For short-term treatment of post-operative pain For obstructive airway disease For dementia of Alzheimer’s type For atopic dermatitis For gastric ulcer Antibiotic For osteoarthritis & soft tissue injury Anti-fungal Anti-diabetic Membrane permeability enhancer Anti-epileptic For bacterial conjunctivitis For schizophrenia Immunosuppressant Anti-cancer Anti-malaria Anti-psychotic Anti-fungal Antibiotic Contd.… Appendix-I List of Recently Approved New Drugs and Combinations 465 …Contd 229 Diclofenac Transdermal Patch 230 Gatifloxacin Eye Ointment 231 Nimesulide Injection 232 Isotretinoin Gel 233 Levosalbutamol rotacaps & inhaler 234 Celecoxib Injection 235 Orlistat 236 Duloxetine HCl 237 Delfazacort 238 Atomoxetine HCl 239 Ursodeoxycholic acid S.R Capsule 240 Methylphenidate Hcl E.R tablet 241 Calcium Polycarbophil 242 Imiquimod Cream 243 Entacapone 244 Levocetirizine Syrup 245 Pitavastatin 246 Bacillus calusii spores suspension 247 Diflorasone Diacetate Cream 248 Azelaic acid Cream 249 250 251 252 253 Levodropropizine oral suspension Duloxetine HCl Levofloxacin Ophthalmic Solution Metformin Oral Solution Tirofiban injection 254 Stavudine powder for suspention 255 Erdosteine 256 Levetiracetam 257 Esomeprazole Sodium for Injection 258 259 260 261 262 Rupatadine Acesulfame Potassium S(–) Metoprolol Succinate S.R R(–) Ondansetron Balanced salt intraocular irrigating solution enriched with glutathione dextrose, bicarbonate For pain relief Ophthalmic use Veterinary use For acne For obstructive airway disease For acute pain Anti-obesity Anti-depressant Anti-asthma, anti-arthritis For ADHD For dissolution of gall stones For ADHD For constipation For warts in adults For Parkinson’s disease For allergic rhinitis & urticaria Lipid lowering agent For alteration of intestinal bacterial flora For corticosteroid responsive dermatoses For the treatment of inflammatory papules and pustules of mild to moderate rosacea For non-productive cough in adults Anti-depressant For susceptible bacterial conjunctivitis For type-II diabetes mellitus For acute coronary syndrome including patients undergoing PTCA or atherectomy For HIV-1 infusion For chronic obstructive brochilits As adjunctive therapy in treatment of partial onset seizures in adults with epilepsy For GERD in patients with esophagitis and/or severe symptoms of reflux as an alternative to oral therapy when oral intake is not appropriate For perinial allergic rhinitis As sweetener in pharmaceutical preparation For hypertension For chemotherapeutic induced nausea and vomiting For intraocular irrigating during intraocular surgical procedures Contd.… 466 Appendices …Contd 263 Intralipid 264 Montelukast Granules For patients with essential fatty acid deficiencies For prophylaxis and chronic treatment of asthma in adult and pediatric patients of 12 months age and older 265 Bortezomib for injection For the treatment of myeloma patients 266 Nelfinavir For HIV patients 267 Sevelamer For control of serum phosphorus in patients with chronic kidney disease and hemodialysis 268 S(–) Pantoprazole For gastric ulcer, duodenal ulcer & GERD 269 R(–) Ondansetron oral Solution For chemotherapy, induced nausea and vomiting 270 Emtricitabine For HIV infection in adults 271 Eplerenone For hypertension 272 Strontium Ranelate Granules For post-menopausal women with osteoporosis 273 Midazolam Maleate Bulk Anesthetic 274 Calcium Polycarbophil For IBS 275 Testosterone Gel For replacement therapy in male with testosterone deficiencies and hypogonadotropic hypoganadism 276 Erlotinib Hydrochloride For metastatic non-small cell lung cancer 277 Chloroquine Phosphate eye drops For dry eye syndrome 278 Mecobalamine E.R tablet For neuropathic pain 279 Olmesartan Medoxomil Anti-hypertension 280 Ursodeoxycholic Acid S.R Tablet Addl strength 281 Feropenem Sodium Anti-bacterial 282 Saquinavir (as mesylate) 500 mg tablet Addl strength 283 Pramipexole Di-hydrochloride For Parkinson’s disease 284 Phenytoin Sodium 300 mg tablet Addl strength 285 Tenofovir Disproxil Fumarate Anti-HIV 286 Bivalirudin Injection Anti-coagulant in PTCA 287 Efavirenz oral solution Anti-AIDS 288 Didanosine Powder for oral solution Anti-AIDS 289 Sodium Valproate C.R Tablet (750/1000 mg) Addl strength 290 Oxcarbazepine S.R Tablet Anti-epileptic 291 Acitretin For sever psoriasis in adults 292 Dried IVY Leaf Extract (7.5 gm/100ml) Cough syrup 293 Ketorolac Tromethamine Eye drops Ophthalmic 294 Levetiracetam oral Solution Anti-epileptic 295 Zinc (Gluconate) oral solution For acute diarrhoea 296 Trimebutine Maleate For IBS 297 Oseltamivir (as phosphate) Capsule & oral suspension For influenzae 298 Cetrizine HCl drops Anti-histaminic Contd.… Appendix-I List of Recently Approved New Drugs and Combinations 467 …Contd 299 300 301 302 303 304 305 306 Lanthanum Carbonate Chewable tablet Sodium Hyaluronate eye drops Voglibose Lactitol Sachet Aspirin Bolus Pregabalin Methotrexate Topical gel Testosterone Spray 307 308 309 310 311 312 313 314 315 316 317 318 319 Omeprazole Powder for suspension Doxazosin (as Mesylate) E.R Tablet Phenylephrine Eye drops Entecavir Tablet & oral solution Travoprost Eye drops Atomoxetine (as HCl) Sachet Levofloxacin oph solu Zonisamide Methimazole Caspofungin Acetate injection Cefprozil Powder for oral suspension Ciclesonide Inhaler Pegaptinib Sodium Injection 320 321 322 323 324 325 Dexibuprofen Moxifloxacin Eye Ointment Erdosteine Powder for oral suspension Doxofylline Zanamavir inhalation powder Testosterone Transdermal Spray 326 327 328 329 330 331 332 333 334 335 Cefetamet Pivoxil HCl oral suspension Voriconazole Powder for oral solution Aceclofenac S.R tablet Desflurane liquid for inhalation Levetiracetam Oral Solution Atomoxetine Fluorescein Sodium Solution for Injection Cefditeron (as pivoxil) Sodium Hyaluronate Cream Saquinavir For the treatment of hyperphosphatemia Ophthalmic use anti-diabetic For the treatment of consipation For Veterinary use For neuropathic pain Psoriasis For replacement therapy in males with testosterone deficiency Anti-ulcer For hypertension For ophthalmic use For chronic Hepatitis-B infection For glaucoma & ocular hypertension For ADHD Ophthalmic Anti-epileptic For hyperthyroidism For invasive candidiasis fungal infection Antibiotic For persistent Asthma For neovascular (wet) age related macular degeneration For OA, RA & ankylosing spondylitis For ophthalmic use For chronic obstructive bronchitis For bronchila asthma & COPD For influenzae For replacement therapy in males with testosterone deficiency Antibiotic Anti-fungal NSAID For induction & maintenance of anaesthesia Anti-epileptic For ADHD Ophthalmological diagnostic agent Antibiotic For leg ulcer, diabetic ulcer etc Anti-AIDS Contd.… ... gall stones For ADHD For constipation For warts in adults For Parkinson’s disease For allergic rhinitis & urticaria Lipid lowering agent For alteration of intestinal bacterial flora For corticosteroid... deficiency Anti-ulcer For hypertension For ophthalmic use For chronic Hepatitis-B infection For glaucoma & ocular hypertension For ADHD Ophthalmic Anti-epileptic For hyperthyroidism For invasive candidiasis... (Hepatitis-B) NSAID For osteoarthritis Anti-diarrhoeal For topical use Sweetening Agent For neurogenic bladder disorder For parkinson’s disease For gastric and Deudonal Ulcers & GERD For BPH Anti-epileptic