Drugs approved in India from 1st January 2015 till present

                         Drugs approved from 1st January 2015 till present

S.NO Name Of Drug Indication Date of

Approval

1 Levocetirizine ODS

2.5/5mg

(Additional dosage form)

For allergic rhinitis and chronic urticaria 14.1.15
2 Decitabine Injection

30mg/vial

(Additional pack size)

1. 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 sideroblasts, 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.

2. for the treatment of adult patients  aged 65 yrs and above with newly diagnosed de novo or secondary acute myeloid leukemia, according to WHO classification, who are not  candidates for  standard induction chemotherapy.

13.2.15
3 Meloxicam  ODT 7.5/15 mg

(Additional dosage form)

Non-steroidal anti-inflammatory 23.2.15
4 Ruxolitinib Tablet 5/15/20mg (Additional indication) Treatment of patients with polycythemia vera who are resistant to or intolerant of hydroxyurea. 23.2.15
5 Gadopentetic acid dimeglumine   salt injection 469mg/1ml (0.5mmol)

(Addition al indication)

For   use   in   MRI   in   adult   patients   to   facilitate visualization of lesions with abnormal vascularity in the body (excluding heart) 23.2.15
6 Pazopanib Tablet 200/400mg

(additional indication)

For the treatment of patients with advanced Soft Tissue

Sarcoma (STS) who have received prior chemotherapy.

23.2.15
7 Eribulin  mesylate  solution for injection 0.88mg in 2ml vial (Add. Indication) For the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic  regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments. 18.2.15
8 Abiraterone acetate Tablet

250 mg (Additional

Indication)

For the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly syptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated, with prednisone or prednisolone. 27.3.15
9 Indomethacin  Injection 1mg/vial

(add.Dosage form)

To close a hemodynamically significant patent ductus arteriosus (PDA) in premature infants weighing between 500g and 1750g when after 48 hrs. usual medical management (e.g. fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective. Clear-cut clinical evidence of hemodynamically significant patent ductus arteriosus should be present, such as respratory distress, a continous murmur, a hyperactive precordium, cardiomegaly and pulmonary plethora on chest X-ray. 30.4.15
10 Ketorolac ODS 10mg

(Add. Dosage form)

For the treatment of short-term management of post-operative pain and musco-skeletal pain. 29.4.15
11 Tiamulin  hydrogen fumarate     solution for injection 162 mg/ml(add. Dosage form) For treatment and prevention of swine dysentery caused by Branchyspira hydodysenteriae.The product is not appropriate for use for the prevention of disease at the level of herd treatment but should only be used for prevention  of  swine  dysentery  in  individual  animals with a known history of exposure  to diseased animals. 17.4.15
12 Montelukast Orally Disintegrating             Strips 4mg/5mg/10mg           (add. Dosage form) For the Relief of perennial allergic rhinitis in adults & pediatric patients 6 months of age and older 29.05.15
13 Apixaban  Tablets  2.5/5mg (add. Indication) Treatment   of   deep   vein   thrombosis   (DVT)   and pulmonary Embolism (PE), and prevention of Recurrent DVT and PE in adult patients. 29.05.15
14 Ruxolitinib 10mg

(add. Strength)

1.  For  the  treatment  of  patients  with myelofibrosis ncluding primary myelofibrosis, post-polycythemeia vera myelofibrosis or post-essential thrombocythemia myelofibrosis

2. Treatment of patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.

29.05.15
15 Lorazepam   Orodispersible Tablet  1mg/2mg(add. Dosage form) For the management of anxiety disorders or for the shortterm relief of symptoms of anxiety or anxiety associated with depressive symptoms. 29.05.15
16 Brimonidine topical  gel 0.33%(Add.Dosage form/indication) For the topical treatment of persistent   (non-transient) facial erythema of rosacea in adults 18 years of age or older. 18.6.15
17 Rivaroxaban  tablet

2.5mg (add. strength)

Rivaroxaban    2.5mg    tablet, co-administered    withAcetylsalicylic acid (ASA) alone or with ASA plus Clopidogrel   or   Ticlopidine,   is   indicated   for   the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers. 13.7.15
18 Lamotrigine ER Tablet

25mg/50mg/100mg/200mg

Add-on therapy for partial and secondary generalised tonic-clonic seizures 6.8.12
19 Feracrylum 3% solution For  the  management  of  post-operative  wound  cuts, Abrasions as an Haemostatic agent cum anti-septic. 13.02.2002
20 Feracrylum 3% gel For  the  management  of  post-operative  wound  cuts, Abrasions as an Haemostatic agent cum anti-septic. 13.02.2002
21 Arteether  injection

150mg/ml

Indicated   for   the   treatment   of   severe   malaria including cerebral malaria and as a second line in chloroquine resistant malaria cases only. 03.12.2010