List of Approved Drug for Marketing in India in the
|S. NO||APPROVED DRUG||INDICATION||APPROVAL DATE|
|1.||Hydrocortisone Aceponate 0.584mg/ml Cutaneous Spray Solution (Vet.)||For symptomatic treatment of inflammatory and pruritic dermatosis in dogs.||06.01.17|
|2.||Dexlansoprazole Delayed Release Capsule 30/60mg & Bulk||
For the treatment of
i) Healing of all grades of erosive esophagitis (EE).
ii) Maintaining healing of EE and relief of heartburn.
iii) Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD).
|3.||Carfilzomib Sterile Lyophilized Powder for Injection 60mg/vial (50ml vial)||
Relapsed or refractory multiple myeloma
Dabrafenib 50mg/75mg Capsules
As a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an appropriate test.
In combination with Trametinib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an appropriate test.
Trametinib 0.5mg/2mg Tablets
(Trametinib Dimethyl Sulfoxide)
|As a monotherapy and in combination with Dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an appropriate test.||18.01.17|
|6.||Alectinib 150mg Capsules (Alectinib Hydrochloride)||For the treatment of patients with anaplastic lymphoma kinase (ALK)-Positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to Crizotinib.||23.01.17|
Eliglustat 84mg Capsules
(Eliglustat Tartrate or Hemitartrate Salt)
|For the long term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an appropriate test.||31.01.17|
|8.||Pasireotide long-acting release 20/40/60mg powder for suspension for injection (Additional Indication) (Pasireotide pamoate)||For the treatment of patients with acromegaly who have had an inadequate response to surgery and/ or for whom surgery is not an option.||14.02.2017|
|9.||Etonogestrel 68 mg implant||For use by women to prevent pregnancy.||15.02.2017|
Bepotastine Besilate 1.5 %w/v Ophthalmic solution
|For the treatment of itching associated with allergic conjunctivitis||22.02.2017|
|11.||Dienogest 2mg Tablets||
For the management of Pelvic pain associated with Endometriosis
Eprinomectin 0.5% for beef and dairy cattle (vet.)
|It is indicated for the treatment and control of gastrointestinal roundworm (including inhibited Ostertagia ostertagi), lungworm, grubs, sucking and biting lice, chlorioptic and sarcoptic-mange mites, and horn flies in beef and dairy cattle of all ages, including lactating dairy cattle.||14.03.2017|
|13||Bepotastine Besilate 10 mg Tablets||For the treatment of allergic rhinitis||27.03.2017|
|14||Prucalopride 1mg/2mg Tablet (Prucalopride Succinate)||For the treatment of chronic idiopathic constipation in adults in whom laxatives fail to provide adequate relief||13.04.2017|
|15||Teriflunomide 14 mg tablets||For the treatment of patients with relapsing form of multiple sclerosis||13.04.2017|
|16||Pomalidomide 1mg/2mg/3mg/4mg Capsules||In combination with dexamethasone, for patient with patient multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.||01.05.2017|
|17||Sofosbuvir 400 mg +Velpatasvir 100 mg Tablet & Bulk||For the treatment of adult patients with -chronic Hepatitis C virus, Genotype 1,2,3,4,5 or 6 infection.-Without cirrhosis or with compensated cirrhosis-With decompensated with chronic for use in combination with Ribavirin||04.05.2017|
Osimertinib 40 mg/80 mg Film coated Tablets
For the treatment of patient with metastatic epidermal growth factor receptor (EGFR) T790 M mutation-positive non-small cell lung cancer (NSCLC), as detected by an appropriate test, whose disease has progressed on or after EGFR TKI therapy.
|19||Argatroban Hydrate Injection 250 mg/2.5 ml||
1) For prophylaxis or treatment of thrombosis in adult patients with Heparin induced thrombocytopenia (HIT).
2) As an anticoagulant in adults patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary intervention (PCI)
|20||Fluralaner chewable tablets 112.5 mg/250 mg/500mg/1000mg/1400 mg (Vet.)||For the treatment of tick and flea infestations on dogs for 12
weeks. This veterinary medicinal product is a systemic insecticide and
acaricide with a long duration of action that provides immediate
and persistent tick (adult and juvenile Ixodes ricinus, Ixodes
hexagonus, Ixodes scapularis, Ixodes holocyclus, Dermacentor
reticulates, Dermacentor variabilis and Rhipicephalus sanguineus) and
flea (Ctenocephalides felis and Ctenocephalides canis) killing activity
for 12 weeks.
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance. the onset of effect is within 8 hours of attachment for fleas (C. felis) and 12 hours of attachment for ticks (I. ricinus)
The product effectively controls environmental flea population in area to which treated dogs have access.
The product can be used as part of an treatment strategy for the control of Flea Allergy Dermatitis (FAD)
|21||Fluticasone Furoate (100 mg mcg) and Vilanterol Trifenatate (25 mcg) powder for inhalation||Indicated for the maintenance treatment of the airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/ or emphysema and to reduce exacerbation of COPD in patients with an exacerbation history.||29.06.2017|
|22||Mirabegron Prolonged Release Tablet 25 mg /50 mg||Symptomatic treatment of urgency, increased micturition frequency and / or urgency incontinence as may occur in patients with over active bladder (OAB) Syndrome||12.07.2017|
|23||Delamanid 50 mg tablet||For the use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability||02.08.2017|
|24||Mirabegron Prolonged Release Tablet 25 mg /50 mg & Bulk||
Symptomatic treatment of urgency, increased micturition frequency and / or urgency incontinence as may occur in patients with over active bladder (OAB) Syndrome
|25||Efonidipine Hydrochloride Ethanolate Bulk & Tablets 10 mg/20mg/40mg||
Indicated for the management of
• Renal parenchymal hypertension
|26||Brivaracetam Film Coated Tablets 50mg/75mg/100mg||As adjunctive therapy in the treatment of partial -onset seizures in patients 16 years of age and older with epilepsy||07.09.2017|
|27||Treosulfan Bulk & injection 5g/vial||For the conditioning treatment prior to haematopoetic stem-cell transplantation||26.09.2017|
|28||Ribociclib 200 mg Film coated Tablets||In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of post menopausal women with the hormone receptor (HR)-Positive, human epidermal growth factor receptor 2 (HER2)-Negative advanced or metastatic breast cancer||27.09.2017|
|29||Dienogest Bulk & 2mg Tablet||For the management of Pelvic pain associated with Endometriosis||28.09.2017|
|30||Apremilast bulk & film coated tablets 10 mg/20 mg/30 mg||for treatment of patients with moderate to severe plaque psoriasis who are candidate for phototherapy or systemic therapy||13.10.2017|
|31||Arbekacin bulk & Injection 200mg/4ml||Treatment of following infections caused by Methicillin resistant Staphylococcus aureus (MRSA)", sepsis pneumonia||20.10.2017|
Benestermycin Intra-mammary suspension (vet.)
|For the treatment of subclinical mastitis at drying off, and the prevention of new bacterial infections of the udder during the dry period in dairy cows, caused by bacteria susceptible to penicillin and framycetin||03.11.2017|
|33||Midostaurin 25 mg Capsules||
• In combination with standard induction and consolidation chemotherapy followed by single agent in maintenance of therapy for adult patients with newly diagnosed with acute myeloid leukemia (AML) who are FLT-3 Mutation positive.
• For the treatment of adult patients with advanced systemic mastocycosis (Advanced SM)
|34||Tenofovir Alafenamide Fumarate bulk & 25 mg capsules||For the treatment of chronic Hepatitis B virus infection in adults with compensated liver disease||10.11.2017|
|35||Arteolane Maleate and Piperaquine phosphate Dispersible tablets (37.5 mg +187.5 mg||
Indicated in children aged 6 months to 12 years for the treatment of :
- Acute uncomplicated Plasmodium falciparum malaria infection
- Acute uncomplicated Plasmodium Vivax malaria infection
|36||Macitentan Bulk and Tablets 10 mg||Macitentan is an endothelin receptor antagonist (ERA)l indicated for the treatment of Pulmonary arterial hypertension (PAH, WHO group I) to delay disease progression||07.12.2017|