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List of Approved Drug for Marketing in India
(from 01.01.2012 to 31.12.2012)

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

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.

15 Ticagrelor Tablet 90mg For the prevention of thrombiotic events (cardiovascular death, myocardial infarction and stroke) in patients with Acute coronary syndromes (ACS) unstable angina, non ST elevation Myocardial infarction (STEMI) including patients managed medically, and those who are managed with percutaneous those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG) 01.07.12
16 Clenbuterol Hydrochloride Solution for injection 30mcg/ml
For the treatment of equine respiratory
diseases in horses where airway obstruction
due to bronchospasm and/or accumulation of mucus is contributing factor and improved
muco-ciliary clearance is desirable.
The product should be used alone or as an adjuvant therapy. The product is of particular value in cases of:                                                                 -   Acute, sub-acute and chronic
infections where the presence of mucus and/or
micro-organisms may stimulate bronchospam e.g.
Bronchitis, broncholitis and Bronchopneumonia

- Acute, sub-acute and chronic respiratory allergies.
 - Chronic obstructive pulmonary disease (COPD
17 Apixaban Tablets 2.5mg
Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.
18 Ethyl esters of iodized fatty acids of poppy seed oil solution for injection 48%.
In Diagnostic Radiology:
Lymphography and
Diagnosis of liver lesions.
(Diagnosis of the spread of malignant lesions,
whether hepatic or not, by selective hepatic arterial injection).

In Interventional Radiology:
Embolization with surgical glues.
(In association with surgical glues during vascular embolizations).

In Endocrinology:
 Prevention of iodine deficiency disorders.
(This treatment should only be used when other methods of supplementation,
particularly iodization of salt and/or drinking water, cannot be undertaken)
19 Conivaptan Hydrochloride Injection 20mg/4ml. For the treatment of euvolemic  hyponatremia (e.g. the syndrome of inappropriate secretion of antidiuretic hormone , or in the setting  of hypothyroidism, adrenal insufficiency, pulmonary disorders, etc.) in hospitalized patients. 21.08.2012
20 Colesevelam Hydrochloride Tablets 625mg & Sachets  for oral suspension 3.75gm/1.875gm. Indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin).
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
21 Tolvaptan Tablets 15/30mg For the treatment of clinically significant hypervolemic and euvolemic hyponatremia [serum sodium < 125mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure, cirhossis, and syndrome of inappropriate antidiuretic hormone (SIADH). 06.09.2012
22 Agomelatine Tablets 25mg For the treatment of major depression in adult patients aged 18 – 65 years only with normal liver functions. 10.09.2012
23 Almotriptan Tablet 6.25mg/12.5mg For acute treatment of migraine attacks with a history of migraine with or without aura in adults.
24 Choline Fenofibrate DR Capsule 45mg/135mg & DR Tablet 45mg/135mg. For treatment of mixed lipidemia in combination with statins, severe hypertriglyceridemia. 01.11.12
25 Trimethoxysilyl Quaternary Ammonium Chloride solution for spray inanimate surfaces for disinfection 0.71%.
Surface protectant and disinfectant for persistent disinfection of all inanimate surfaces. Effective upto 14 days. 16.11.12
26 Imipenem IP (Sterile) eq to anhydrous Imipenem 1 g + Cilastatin Sodium IP (sterile) eq to Cilastatin 1 g Powder for Injection (Additional strength) For the treatment of serious lower respiratory tract infections, urinary tract infections, intra-abdominal, bone and joint infection, endocardities and bacterial septiceimia 28.06.12
27 Diclofenac Diethylamine BP 4.64 % w/v Eq. to Diclofenac Sodium IP 4.00 %  + Absolute Alcohol IP 10.00 % v/v Topical Solution For the Treatment of Acute Lower Back Pain 21.12.12





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