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Monday, July 9, 2012

List of Approved Drug for Marketing in India (from 01.01.2012 to till date)

S. No. Name of Drug Indication Date of issue
1 Ornidazole IP 1 % w/w + Povidone Iodine IP (0.5% w/w available Iodine) 5% w/w Ointment For the prevention and treatment of surgical wound infections in adult patients undergoing surgery 03.01.12
2 Aceclofenac IP (Sustained released pellets) 200mg/200mg + Thiocolchicoside IP (Sustained released pellets) 8mg/16mg Capsules. (New Dosage Form) For the treatment of acute inflammation conditions associated with spasm in adults only 04.01.12
3 Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 20mcg/20mcg Respirator suspension. (Additional Indication) In the regular treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with frequent symptoms and a history of exacerbations. 04.01.12
4 Diclofenac Sodium IP (Enteric coated granules) 50mg + Eperisone Hcl IP (Tablet) 50mg Hard Gelatin Capsules. (New Dosage Form) For the treatment of Patients with acute musculoskeletal spasm associated with low back pain 06.01.12
5 Degarelix for Injection 80mg / 120mg per vial For the treatment of adult patients with advanced hormone dependent prostate cancer. 19.01.12
6 Linagliptin film coated Tablet 5mg As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Important limitations of use: 1. Should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. 2. Has not been studied in combination with insulin.
7 Eribulin mesylate solution for injection 0.88mg / 2ml vial For the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments. 27.01.12
8 Plerixafor Injection 20mg/ml In combination with Granulocyte Colony Stimulating Factor (G-CSF) to enhance mobilisation of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous hematopoeitic stem cells transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma whose cells mobilise poorly. 31.01.12
9 Cephalexin IP (as monohydrate) 200mg + Kanamycin IP (as monosulphate) 100,000 IU Suspension per 10 gm Intramammary Suspension For the treatment of clinical mastitis in lactating dairy cows for bacteria susceptible to the combination of cephalexin and kanamycin such as Staphylococcus aureus, Streptococcus dysgalactiae, Streptococcus uberis and Escheria coli. 07.03.12
10 Mucotrol Concentrated Oral Gel Wafer. For the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis (may be caused by chemotherapy or radiotherapy).
Irritation due to oral surgery and traumatic ulcers caused by braces or ill fitting dentures of diseases and for diffuse apthous ulcers.
11 Ulinastatin for Injection 50000 IU / 100000 IU For the treatment of severe sepsis. 03.04.12
12 Sterile Solution for Peritoneal Dialysis
Each 1000 ml contains:  Calcium chloride dihydrate 0.184 g/l + Glycine 0.51 g/l + L- Alanine 0.951 g/l + L- Arginine 1.071 g/l + L- Isoleucine 0.85 g/l + L- Histidine 0.714 g/l + L- Leucine 1.02 g/l + L- Lysine (as Hcl) 0.955 g/l + L-Methionine 0.85 g/l + L- Phenylalanine 0.57 g/l + L-Proline 0.595 g/l + L- Serine 0.51 g/l + L- Threonine 0.646 g/l + L-Tryptophan 0.27 g/l + L-Tyrosine 0.3 g/l + L-Valine 1.393 g/l + Magnesium chloride hexahydrate 0.051 g/l + Sodium chloride 5.38 g/l + Sodium lactate 4.48 g/l
As Nutritional supplements for malnourished renal failure patients (Albumin concentration lower than 35 g/litre) being maintained on peritoneal dialysis. 18.04.12
13 Blonanserin Tablet 2mg/4mg/8mg For the treatment of Schizophrenia in adult patients when first line treatment is ineffective. 24.04.12
14 Etravirine Tablet 100mg In combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other antiretroviral agents.
It should be used only in situations where other treatments have failed or cannot be used because of side effects.


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