FIRST NATIONAL DAILY MEDICAL NEWSPAPER OF INDIA
24th November Tuesday
DCI Approved drugs from jan to August 2009 (Revisiting 2009 series)
1. Zoledronic Acid Injection 5mg/100ml (additional indication) was approved for the treatment of osteoporosis in post menopausal women and in men who are at increased risk of fracture, including those with a recent low trauma hip fracture on 07.01.09.
2. Misoprostol Tablet 600mcg, (additional strength) was approved on 09.1.09.
3. Acebrophylline Syrup 10mg/ml was approved for the treatment of adult patients with chronic obstructive pulmonary disease (COPD) and bronchial asthma on 09.1.09.
4. Selamectin Topical Solution (for veterinary use) 60mg/120mg per ml was approved on 09.01.09 for (I) the treatment and lasting prevention of flea infestations, treatment and control of flea allergy dermatitis, prevention of heartworm disease, treatment and prevention of ear mites in dogs and cats; (II) the treatment and prevention of sarcoptic mange, roundworms and for control of tick infestations in dogs.
5. Methylcobalamin 1500mcg + Calcium 200mg + Calcitriol 0.25mcg + Folic Acid 1.5mg + Pyridoxine 3mg Capsules were approved for the treatment of vitamin deficiency states in adults on 14.01.09.
6. Metoprolol Tartrate Tablet 50 mg (additional indication) was approved for adjunct to the treatment of hyperthyroidism on 14.01.09.
7. Cinacalet (as HCl) Tablet 30/60/90mg was approved for the treatment of secondary hyperparathyroidism in patients with chronic kidney diseases (CKD) on dialysis and for hypercalcemia in patients with parathyroid carcinoma on 14.01.09.
8. Mycophenolate Mofetil Capsule 250mg, Tablet 500mg, Oral suspension 200mg/ml (additional indication) was approved for the prophylaxis of acute organ rejection in patients receiving allogenic hepatic transplantation on 23.01.09.
9. Liquid Paraffin 1.25ml + Milk of Magnesia 3.75ml + Sodium Picosulphate 3.33mg per 5ml was approved for symptomatic treatment of constipation in adults on 29.01.09.
10. Ranolazine 1000mg ER Tablet (additional strength) was approved for chronic angina on 31.01.09.
11. Hyaluronic Acid (cross linked) Pre-filled Syringe 18mg/0.6ml and 24mg/0.8ml was approved for intradermal implantation and facial soft tissue augmentation on 31.01.09.
12. Caspofungin Acetate Injection (additional indication) was approved on 31.01.09 for (i) Empirical therapy for presumed fungal infections in febrile neutropenic patients (ii) Treatment of candidemia and the following candida infections: intra-abdominal abscesses, peritonitis and pleural space infections (iii) Treatment of esophageal candidiasis (iv) Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies (i.e. amphotericin B, lipid formulations of amphotericin B, and/or itraconazole).
13. Micafungin (as sodium) Powder for solution for infusion 50mg/vial was approved for the treatment of patients with candidemia, acute disseminated candidiasis, candida peritonitis, abscess and esophageal candidiasis. For the prophylaxis of candida infection in patients undergoing hematopoietic stem cell transplantation (HSCT) on 31.01.09.
14. Loteprednol Etabonate Nasal Spray 0.1% w/v was approved for prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis on 31.01.09.
15. Rasagiline (as mesylate) Tablet 0.5mg/1mg was approved for the treatment of signs and symptoms of idiopathic Parkinson's disease as initial monotherapy and as an addition to levodopa on 31.01.09.
16. Nicotine Polacrilex Gum 2mg & 4mg (additional indication) was approved to reduce withdrawal symptoms, including nicotine craving due to cigarette quitting and other tobaccos like guthka and khaini on 03.02.09.
17. Closantel Injection 100mg/ml (for veterinary use.) was approved for infestation of trematodes, nematodes, cestodes and arthropods of domestic animals, including milch and other food producing animals on 05.02.09.
18. Lornoxicam 4mg + Paracetamol 500mg Film Coated Tablet was approved for short term use in acute painful and inflammatory conditions in adults on 05.02.09.
19. Cetrimide 15% w/v + Chlorhexidine Gluconate 7.5% v/v + Isopropyl Alcohol 7.5% v/v Concentrate Solution was approved for cleansing of physically contaminated wounds and for
preoperative disinfection on 09.02.09.
20. Ketoconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) Solution was approved for the treatment of dandruff on 09.02.09.
21. Doripenem (as monohydrate) Injection 250mg/500mg was approved for the treatment of nosocomial pneumonia in adults on 16.02.09.
22. Halobetasol Scalp Approved 0.05% w/v was approved for the relief of inflammatory and puritic manifestation of corticosteroid responsive dermatosis on 18.02.09.
23. Nicotine (as Polacrilex) Lozenges 2mg and 4mg was approved to reduce the withdrawal symptoms, including nicotine craving, associated with quitting cigarettes and chewed tobacco and guthka containing tobacco on 18.02.09.
24. Tranexamic Acid Tab SR 750mg was approved for the treatment of menorrhagia on 20.02.09.
25. Betahistine Mesilate Tablet 6mg/12mg was approved for the treatment of dizziness and feeling of dizziness resulting from Meniere's disease, Meniere's syndrome and vertigo on 20.02.09.
26. Abatacept Injection 250mg/vial (additional indication) was approved in moderately to severely active rheumatoid arthritis in adults and may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists on 20.02.09.
27. Anidulafungin Injection (Lyophilized powder) 50mg/100mg per vial was approved for the treatment of invasive candidiasis including candidemia and esophageal candidiasis in adult patients on 23.02.09.
28. Hydroquinone 2%+ Tretinoin 0.05% + Hydrocortisone1% Cream was approved for the treatment of patients with skin hyperpigmentation on 23.02.09.
29. Doxyphylline 400 mg + Terbutaline 5mg Tablet was approved for the treatment of asthma and chronic obstructive pulmonary disease in adult patients on 23.02.09.
30. Hydroquinone 20mg + Tretinoin 0.25mg + Fluocinolone Acetonide 0.1mg per gm Cream was approved for the treatment of melasma on 23.02.09.
31. Ketoconazole 2% + Zinc Pyrithone 1% Lotion was approved for the treatment of pityriasis and dandruff of the scalp on 23.02.09.
32. Lamivudine 30mg + Zidovudine 60mg + Nevirapine 50mg Oral Suspension (Tablets for oral Suspension) was approved for the treatment of HIV patients on 23.02.09.
33. Glibenclamide 5mg + Pioglitazone 15mg + Metformin 500mg Film-Coated Tablet was approved as third-line treatment of type 2 diabetes mellitus when diet, exercise and/or single agents and second-line therapy with two drugs do not result in adequate glycemic control on 23.02.09.
34. Aceclofenac 100mg + Tizanidine 2mg Film Coated Tablet was approved for the treatment of acute low back pain in adult patients on 23.02.09.
35. Octinoxate 7.5% + Avobenzone 3% + Oxybenzone 3% + Titanium dioxide 2% lotion was approved as sunscreen lotion for prevention of sunburn skin on 23.02.09.
36. Cetirizine 5/10mg + Ambroxol 30mg per 5ml syrup was approved for the symptomatic relief of productive cough associated with allergic rhinitis, when both anti-histamine and mucolytic agents are desired on 23.02.09.
37. Lidocaine Lozenges 200/300mg was approved for single agent anesthesia in upper gastrointestinal endoscopy on 26.02.09.
38. Calamine 8% + Liquid Paraffin 10% Lotion was approved as antipruritic and smoothening agent on 26.02.09.
39. Nifedipine 0.3% + Lidocaine1.5% Cream was approved for the treatment of anal fissures on 26.02.09.
40. Quinapril 20mg + HCTZ 25mg Film Coated Tablet was approved for the treatment of mild to moderate hypertension in adult patients (in whom combination therapy is appropriate) who have been stabilized on the individual components given in the same proportion on 26.02.09.
41. Levodopa 100/100/250 + Carbidopa 10/25/25mg Mouth Dissolving Tablet was approved for the symptomatic symptoms of idiopathic Parkinson's disease on 04.03.09.
42. Paliperidone ER Tablet 1.5mg was approved for additional strength on 04.03.09.
43. Losartan 100mg + HCTZ 25 mg Tablet was approved for additional higher strength on 16.03.09.
44. Darunavir (as ethanolate) Tablet 300mg was approved for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those patients with HIV-1 strains resistant to more than one protease inhibitor when co-administered with 100mg ritonavir, and with other antiretroviral agents on 19.03.09.
45. Ropivacaine HCl Injection.2/5/7.5/10mg was approved for the production of local or regional anesthesia for surgery and for acute pain management on 19.03.09.
46. Butaphosphan 100g + Methyl Hydroxybenzoate 1gm + Cyanocobalamine 50 gm Oral powder (Veterinary Drug) was approved as vitamin and phosphorous supplement for livestock, shrimp and fish on 19.03.09.
47. Fluticasone Furoate Nasal Spray 27.5mcg per spray was approved for the treatment of symptoms of allergic rhinitis on 19.03.09.
48. Octinoxate 7.5% + Avobenzone 2% + Oxybenzone 3% + Octocrylene 3%+ Zinc Oxide 2% Lotion was approved for prevention of sunburnt skin on19.03.09.
49. Omeprazole 20/40mg + Sodium Bicarbonate 600mg+ Magnesium Hydroxide 700mg Sachet was approved for additional strength on 19.03.09.
50. Ambroxol 30mg + Levosalbutamol 1mg + Guiphenesin 50mg /5ml Syrup was approved for the symptomatic relief of bronchospasm in bronchial asthma and chronic bronchitis on 19.03.09.
51. Montelukast 4 mg + Levocetirizine 2.5 mg Tablet was approved for additional lower pediatric dose on 19.03.09.
52. Surgical Sealant was approved for use in sealing suture lines along arterial and venous reconstructions on 26.03.09.
53. Lidocaine Patch 700mg in aqueous base (50 mg per gram adhesive) was approved for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin on 26.03.09.
54. Bimatoprost Ophthalmic Solution 0.03% was approved for the treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness on 30.03.09.
55. Trabectedin Powder concentrate of solution for infusion 1 mg/vial was approved for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents on 30.03.09.
56. Acebrophylline Syrup 10mg/ml (additional indication) was approved for the treatment of children (aged 6 to 12 years) with chronic obstructive pulmonary disease (COPD) and bronchial asthma on 30.03.09.
57. Mesalamine PR Tablet 1.2gm was approved for the induction of remission in patients with active, mild to moderate ulcerative colitis on 30.03.09.
58. Mycophenolate Mofetil Tablet 750mg additional strength was approved (same as approved) during liver transplantation on 31.03.09.
59. Ketorolac Tromethamine Gel 2% w/w was approved for the treatment of muscle, joint and post-traumatic stress on 31.03.09.
60. Theophylline 400mg SR + Montelukast 10mg Tablet was approved for the treatment of patients with bronchial asthma on 31.03.09.
61. Hyaluronic Acid Sodium Salt 0.2 gm + Silver Sulfadiazine 1.0 gm/25 gm tube Hyaluronic Acid Sodium Salt 50 mg + Silver Sulfadiazine 1.0 gm/100 gm Gauze Pads impregnated with cream was approved for the treatment of wounds of different etiology on 31.03.09.
62. Telmisartan 80mg + Amlodipine 5mg Tablet Additional higher strength on 31.03.09.
63. Hyaluronic Acid Sodium Salt (i) Each 15gm tube contains: Hyaluronic Acid Sodium Salt 0.2gm/100gm (ii) Sterile Gauze Pads impregnated with cream: Each gauze pad contains Hyaluronic Acid Sodium Salt 50/100mg, was approved for the treatment of wound of different etiology on 31.03.09.
64. Abatacept Injection 250mg/vial (additional indication) was approved for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis/juvenile rheumatoid arthritis in pediatric patients aged 6 years and older who have had an inadequate response to one or more DMARDs such as MTX on 10.04.09.
65. Cetirizine 10 mg + Ambroxol 75 mg SR Tablet was approved for symptomatic relief of productive cough associated with allergic rhinitis, when both antihistamine and mucolytic agents are desired on 13.04.2009.
66. Ciclesonide 200mcg + Formoterol 6 mcg + Tiotropium 9 mcg MDI was approved as third-line treatment of severe cases of COPD, when monotherapy and second-line therapy with two drugs do not respond adequately on 13.04.2009.
67. Each film coated bilayered tablet contains: Metoprolol 25mg/50mg + Chlorthalidone 12.5mg was approved for the treatment of patients with mild to moderate essential hypertension on 13.04.2009.
68. Milnacipran 25/50mg Capsule (additional indication) was approved for the management of fibromyalgia on 15.04.2009.
69. Lornoxicam SR 16mg Tablet was approved for the symptomatic treatment of pain and inflammation in patients of osteoarthritis and rheumatoid arthritis on 25.04.2009.
70. Palonosetron HCl 0.075mg IV Injection (additional strength) was approved for nausea and vomiting on 25.04.2009.
71. Each film coated bilayered tablet contains: Metoprolol 25mg/50mg + Chlorthalidone 6.25 mg/12.5mg was approved for additional strength on 25.04.2009.
72. Albendazole 400 mg + Ivermectin 6 mg Tablet was approved for the treatment of intestinal helminths and suppression of microfilaremia especially with bancrofti infections on 25.04.2009.
73. Decitabine Lyophilized Powder for injection 50mg/20ml vial was approved for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed side-oblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk international prognostic scoring system groups on 25.04.2009.
74. Retapamulin Ointment 1% was approved for the topical treatment of bacterial skin and skin structure infections: primary impetigo, secondarily infected traumatic lesions, secondarily infected dermatoses on 25.04.2009.
75. Calamine 15% w/v + Zinc Oxide 5% w/v + Bentonite 3% w/v + Glycerin 5% w/v + Sodium Citrate 0.05 % w/v Lotion was approved for the treatment of pruritus and prickly heat on 08.05.2009.
76. Medium chain triglycerides 100 gm + Soya oil 80 gm + Omega-3 Acid Triglycerides 20 gm + Egg Lecithin 12 gm + Glycerol 25 gm + Sodium Oleate 0.30 gm + Alpha-tocopherol 0.20 gm + Ascorbypalmitate 0.30 gm + Sodium Hydroxide max. 0.06 gm + water for injection 784 gm emulsion for infusion was approved for the supply of fats, including essential omega-6 fatty acids and omega-3 fatty acids, as part of a parenteral nutrition regimen in adults, if oral or enteral nutrition is impossible, inadequate or contraindicated on 14.05.2009.
77. Sertaconazole Nitrate Powder 2% w/w & Lotion 2% w/v was approved for the topical treatment of the superficial fungal infections of the skin on 02.05.2009.
78. Amlodipine Tablet 5mg/10mg (additional indication) was approved for (i) Reduction of fatal coronary heart disease and non-fatal myocardial infarction, and to reduce the risk of stroke (ii) Reduce the risk of coronary revascularization procedures and the need for hospitalization due to angina in patients with coronary artery disease 02.05.2009.
79. Clindamycin Phosphate Injection 150mg/ml & Clindamycin HCl Capsule 150mg/300mg (additional indication) was approved for prophylaxis of infection in neck and head surgery on 02.05.2009.
80. Lactulose 10 gm + Ispaghula Husk 3.50 gm granule 15 gm sachet was approved for the treatment of chronic idiopathic constipation in adult patients on 16.05.2009.
81. Sucralose was approved for use as sweetener in drug formulations on 09.05.2009.
82. Carvedilol Tablet 3.125/6.25/12.5/25mg (additional indication) was approved to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of ≤ 40% (with or without symptomatic heart failure) on 09.05.2009.
83. Dexketoprofen 12.5 mg/25 mg + Paracetamol 500 mg Film Coated Tablet was approved for the treatment of acute musculoskeletal pain on 18.05.2009.
84. Pregabalin SR Tablet 150/300mg was approved for the treatment of peripheral neuropathic pain in adults on 16.05.2009.
85. Guaiphenesin ER Tablet 1200mg was approved for the treatment of productive cough accompanied by phlegm on 16.05.2009.
86. Everolimus 5/10mg Tablet (additional indication) was approved for treatment of advanced renal cell carcinoma on 16.05.2009.
87. Nimesulide ER 200mg (additional indication) was approved for acute pain in orthopedic, ENT, dental and postoperative conditions on 16.05.2009.
88. Palonesetron Injection 0.25mg/5ml (additional indication) was approved for treatment of post operative nausea and vomiting on 16.05.2009.
89. Bendamustine Hydrochloride Lyophilized Powder Injection 100mg/vial was approved for the treatment of patients with chronic lymphocytic leukemia on 16.05.09.
90. Caffeine (as citrate) 10mg/ml Injection was approved for the short-term treatment of apnea of prematurity of infants between 28 and < 33 weeks gestational age on 16.05.09.
91. Perindopril Arginine 2.5mg/5mg/10mg Film-Coated Tablet was approved for the treatment of arterial hypertension, congestive heart failure and coronary artery disease on 16.05.09.
92. Halobetasol 0.05% w/w + Mupirocin 2.0 % w/w gel was approved for the topical treatment of inflammatory dermatitis with secondary bacterial infection on 16.05.09.
93. Mometasone 0.1 % + Fusidic Acid 2% Cream/Ointment was approved for the treatment of dermatoses where secondary bacterial and/or candidial infection is present on 25.04.09.
94. Thiocolchicoside 8 mg + Etoricoxib 60 mg tablet was approved for additional strength on 25.04.09.
95. Methadone Hydrochloride 5mg/10mg per ml Syrup;5mg/10mg/20mg/40mg tablet was approved for the treatment of opioid dependence and as maintenance treatment for opioid dependence on 28.05.09.
96. Trospium Chloride Film-Coated Tablet 20mg was approved for the treatment of overactive bladder with the symptoms of urinary incontinence, urgency, and urinary frequency on 28.05.09.
97. Arformoterol (as tartrate) 15mcg /2ml Inhalation Solution was approved for the long term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema on 29.05.09.
98. Zolmitriptan 5.0% w/v Benzalkonium Chloride NF 0.01% w/v Nasal spray was approved for the acute treatment of migraine with or without aura in adults on 29.05.09.
99. Dexmedetomidine (as HCl) 100mcg/ml Injection was approved for sedation of initially and mechanically ventilated patients during treatment in an intensive care setting on 29.05.09.
100. Levetiracetam SR Tablet 500/750/1000mg was approved (for epilepsy) on 2.05.2009.
101. Glatiramer Acetate Injection (20mg/ml) and Pre-filled Syringe (20mg/ml) was approved for the reduction of the frequency of relapses in patients with relapsing-remitting multiple sclerosis on 3.06.2009.
102. Yttrium-90 Microspheres Injection (Yttrium-90...3GBq (at the time of calibration) per vial) was approved for the treatment of unresectable metastatic liver cancer from primary colorectal cancer with intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine) on 3.06.2009.
103. Luliconazole Cream 1% was approved for the treatment of cutaneous mycosis viz. Tinea pedis, Tinea corporis, Tinea cruris on 3.06.2009.
104. Magnesium Valproate Prolonged -Release Tablet 600mg was approved (i) For the treatment of generalized or partial seizures as monotherapy or adjunctive therapy (ii) For prophylaxis of migraine headache in adults (iii) For the treatment of manic episodes associated with bipolar disorders on 4.06.2009.
105. Tenofovir Disoproxil Fumarate 300mg was approved for the treatment of chronic hepatitis B in adults on 19.6.2009.
106. Bosentan (as monohydrate) Tablet 62.5/125mg was approved for the treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO Class III or IV symptoms, to improve exercise ability and decrease the rate of clinical worsening on 23.6.2009.
107. Lornoxicam 12 mg SR (additional strength) was approved (as a potent NSAID) on 26.6.2009.
108. Azithromycin SR Granule for Oral Suspension 2000mg was approved for the treatment for mild to moderate susceptible infection including RTI, uncomplicated skin/ skin structure, non gonococcal urethritis, cervicitis on 26.6.2009.
109. Metoprolol 50/50/25 mg + Atorvastatin 20/10/10 mg + Ramipril 10/5/2.5 mg capsule was approved as second- line treatment of patients with both essential hypertension and hypercholesterolemia who are not adequately controlled by combination of an antihypertensive drug plus lipid-lowering agent on 1.07.2009.
110. Methylphenidate ER Tablet 10/20/30mg was approved for the treatment of attention deficit hyperactivity disorder (ADHD) on 10.07.2009.
111. Dasatinib Tablet 100mg (additional strength) was approved (for use in patients with chronic myelogenous leukemia) on 10.07.2009.
112. Voglibose 0.2 mg + Metformin 500mg Tablet was approved as second line treatment of type II diabetes mellitus when diet, exercise and the single agent do not result in adequate glycemic control on 13.7.2009.
113. Combipack of Artesunate Tablet and FDC Tablet of Sulphadoxine + Pyrimethamine Composition:
A. Combipack of 1 strip of 3 tablets of artesunate 25 mg and 1 strip of 1 tablet of sulphadoxine 125mg+ pyrimethamine 6.25 mg.
B. Combipack of 1 strip of 3 tablets of artesunate 50 mg and 1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg.
C. Combipack of 1 strip of 3 tablets of artesunate 100 mg and 1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg.
D. Combipack of 1 strip of 3 tablets of artesunate 200 mg and 1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg.
114. Nevirapine tablet 50 mg for oral suspension mg was approved for the treatment of HIV infection in combination with other antiretroviral agents on 18.7.2009.
115. Desvenlafaxine (as succinate) ER Tablet 50mg/100mg was approved for the treatment of major depressive disorder (MDD) on 18.7.2009.
116. Posaconazole Oral Suspension 40mg/ml was approved for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole. For prophylaxis of invasive aspergillus and candida infections in patients, 13 years of age and older, who are at high risk of developing these infections because of being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy on 18.7.2009.
117. Caffeine Citrate 20mg/ml (equivalent to 10mg of caffeine base) Oral Solution (additional dosage form) was approved for treatment of apnea on 18.7.2009.
118. Amphotericin B Emulsion 5mg/ml (additional indication) was approved for febrile neutropenia in cancer patients on 18.7.2009.
119. Hydroxy Ethyl Starch 10% Solution for Infusion was approved for the treatment of imminent or manifest hypovolemia and shock on 18.7.2009.
120. Naratriptan (as HCl) Tablet 1/ 2.5mg was approved for the acute treatment of migraine with or without aura in adults on 18.7.2009.
121. Colistimethate Sodium Powder for solution for injection/infusion 500000IU and 2000000IU (additional strength) was approved (for use in treating Pseudomonas aeruginosa infection in cystic fibrosis) on 20.7.2009.
122. Simvastatin 20 mg + Ramipril 5mg + Atenolol 50 mg + HCTZ 12.5 mg + Aspirin 100 mg (EC Pellets) capsule was approved for secondary prevention of coronary heart disease/stroke in patients where use of such combination is appropriate on 21.7.2009.
123. Colistimethate Sodium Powder for solution for inhalation 500,000IU / 1,000,000IU / 2,000,000IU was approved for treatment by inhalation of pseudomonas aeruginosa lung infection in patients with cystic fibrosis on 28.7.2009.
124. Ramipril MR Capsule 10mg was approved for the treatment of hypertension/ cardiac failure and myocardial infarction on 30.7.2009.
125. Abacavir Sulfate Tablet 60mg was approved for the treatment of HIV-1 infection in combination with other antiretroviral agents on 1.08.2009.
126. Zoledronic Acid Solution for Infusion (additional indication) was approved for prevention of clinical fractures after hip fracture in men and women on 1.08.2009.
127. Sumatriptan 85 mg + Naproxen 500 mg Tablet was approved for additional strength for the treatment of migraine on 3.08.2009.
128. Aceclofenac(100mg) + Thiocolchicoside (8 mg) Tablet was approved for the treatment of acute inflammation conditions associated with spasm in adults only on 3.08.2009.
129. Oxcarbazepine 150/300/600mg Tablet (additional indication) was approved for treatment of generalized tonic-clonic seizures in adults and children on 13.08.2009.
130. Ofloxacin 2mg + Ornidazole 5 mg per ml Infusion was approved for the treatment of diarrhea of mixed infection in adult patients on 17.08.2009.
131. Clozapine Tablet 200mg (additional strength) was approved / indicated for the management of schizophrenic patients on 19.08.2009.
132. Oxymetazoline Hydrochloride Nasal Spray 50mcg/0.05% w/w was indicated for the relief of stuffy, running nose associated with colds and influenza, also post nasal drip, sinusitis approved on 19.08.2009.
133. Enoxaparin Sodium Injection (additional indication) was approved for treatment of acute ST -segment elevation myocardial infarction including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI) on 19.08.2009.
134. Fluvoxamine Maleate100/150mg ER Tablet was approved for the treatment of obsessive compulsive disorder (OCD) and depression on 19.08.2009.
135. Lidocaine Lozenges 200/300mg (additional indication) was approved for single agent anesthesia in procedure involving the introduction of instrument and tubes into respiratory tract on 19.08.2009.
136. Risperidone long-acting injection (additional indication) indicated as monotherapy or as adjunctive therapy in lithium or valproate for the maintenance treatment of bipolar-1 disorder approved on 29.08.2009.
137. Exemestane 25mg Tablet (additional indication) indicated for adjuvant treatment of post menopausal women with estrogen receptor positive early breast cancer who received two-three years of tamoxifen and then switched to exemestane for completion of total of five years of adjuvant hormonal therapy approved on 29.08.2009.
Dr K K Aggarwal