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LIST OF APPROVED DRUGS IN THE MONTH OF OCTOBER 2009

www.cdsco.nic.in
S.No Drug Name Indication Approval Date
1 Glucosamine sulphate potassium chloride 500 mg + Ibuprofen IP 200mg film coated Tablets For the treatment of adult patients with osteoarthritis of knee and/or hip joints 03.11.2009
2 Methylcobalamin 1500 mcg + Gabapentin SR 600 mg film coated tablets Additional strength 4.11.2009
3 Propofol 1% for injection (Additional Indication) 1. For conscious sedation for surgical and diagnostic procedures 2. for sedation of ventilated patients receiving intensive care 5.11.2009
4 Rupatadine 10 mg + Montelukast 10 mg Tablets For the management of seasonal allergic rhinitis (SAR) 10.11.2009
5 Eperisone 50 mg + Paracetamol 500 mg Tablets For improvement of mytonic conditions caused by neck shoulder arm syndrome , scapulhumeral periarthritis and low back pain in adult patients only 10.11.2009
6 Lafutidine Tablets ....5mg/10mg. For the treatment of:
  • gastric ulcers, duodenal ulcers and stromal ulcers
  • gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis and acute exacerbation of chronic gastritis.
11.11.2009
7 Ramosetron Hydrochloride Tablets 2.5mcg, 5mcg, 0.1mg & Injecton 0.3mg /2ml 1. Tablets 0.1mg & Injection 0.3 - for the prevention and treatment of gastrointestinal symptoms (nausea and vomiting) associated with emetogenic cancer chemotherapy.
2. Tablets 2.5mcg & 5mcg - for the treatment of diarrhoea predominant irritable bowel syndrome.
11.11.2009
8 Tadalafil tablet 20 mg (Additional Indication) For the treatment of pulmonary arterial hypertension 14.11.2009
9 Flurbiprofen Sodium 0.03% Ophthalmic solution USP for the reduction of post-operative inflammatory condition 14.11.2009
10 Dexmedetomidine HCl Injection (Additional Indication) Sedation of non-intubated patients prior to and/or during surgical and other procedure 14.11.2009
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