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List of Approved Drug for Marketing in India in the
Year 2019

S. NO APPROVED DRUG INDICATION APPROVAL DATE
1. Fenspiride hydrochloride film coated extended release tablet 80 mg and Fenspiride hydrochloride bulk

Acute Rhinosinusitis

Moderate persistent asthma as an add- on therapy

04.02.2019
2. Bilastine tablets 20 mg and Bilastine Bulk For symptomatic treatment of allergic rhino-conjuctivitis (seasonal and perennial) and utricaria in adults 06.02.2019
3. Iguratimod film coated tablets 25mg and Iguratimod Bulk For the treatment of active rheumatoid arthritis symptoms 18.02.2019
4.

 

Fingolimod Capsules 0.5mg and Fingolimod hydrochloridebulk
For the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.

 

25.03.2019
5.

Remogliflozin etabonate bulk and Remogliflozin etabonate film coated tablets 100 mg

Indicated in adults aged 18 years and older with type2 diabetes mellitus to improve glycemic control as:-

  • Monotherapy when diet and exercise alone do not provide adequate glyceamic control.
  • Add on therapy with metformin, together with diet and exercise, when these do not provide adequate glyceamic control.

26.04.2019

6. Concentrate of Proteolytic enzyme enriched in Bromelain topical gel Indicated for removal of eschar in adults with deep partial-and full-thickness thermal burns 17.05.2019
7.

 

Menotrophin injection 600 IU/ml, 1 ml & 2 ml multi dose vial (Highly purified)

Menotropin is indicated for the treatment of female and male infertility in the following conditions:
Anovulation , including Polycystic Ovarian Disease (PCOD), in women who have been

unresponsive to the treatment with

Clomiphene citrate.

Women undegoing controlled ovarian hyperstimulation to induce the development of multiple follicles for Assisted Reproductive Technologies (ART).

Hypogonadotropic hypogonadism in men.

 

17.06.2019
8.

Rifapentine 150mg film coated tablet

“For the treatment of latent tuberculosis infection caused by Mycobacterium tuberculosis in adults and children 2 years and older who are at high risk of progression to tuberculosis disease (including those in close contact with active tuberculosis patients, recent conversion to a positive tuberculin skin test, HIV-infected patients, or those with pulmonary fibrosis on radiograph).
Active tuberculosis disease should be ruled out before initiating treatment for latent tuberculosis infection.

Rifapentine Tablets 150mg must always be used in combination with isoniazid as a 12- week once-weekly regimen for the treatment of latent tuberculosis infection”.

08.07.2019

9

FDC of Bictegravir, Emtricitabine and Tenofovir alafenamide 50mg/200mg/25mg tablets

For the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per ml) on a stable antiretroviral regimen for at least 3 month with no history of treatment failure and no known substitutions associated with resistance to Bictegravir, Emtricitabine and Tenofovir alafenamide.

 

 

 

09.08.2019
10 Levomilnacipran ER capsules 20mg/40mg/80mg/120mg For treatment of major depressive disorder 13.08.2019
11 Bosutinib bulk and Bosutinib tablets 100mg, 400mg, 500mg

For the treatmnet of adult patients with:

1) Newly diagnosed chronic phase (CP)

Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+CML)

2) Chronic phase, accelerated phase (AP), or blast phase (BP) Ph+CML with resistance or intolerance to prior therapy.
09.09.2019
12 Algard - R-82 (octyldecyl dimethyl ammonium chloride 6.510 w/w + Dioctyl dimethyl ammonium chloride 2.604% w/w + Didecyl dimethyl ammonium chloride 3.906% w/w + Alkyl dimethyl benzyl ammonium chloride 8.680% w/w

 

Surface disinfectant for persistent disinfection of all inanimate surfaces (Against pathogens as annexed)

 

09.09.2019
13 Algard HWS-256 (didecyl dimethyl ammonium chloride 10.14% w/w + n-Alkyl dimethyl benzyl ammonium chloride 6.76% w/w Surface disinfectant for persistent disinfection of all inanimate surfaces (Against pathogens as annexed) 09.09.2019
14

 

Safinamide methane sulphonate bulk drug and Safinamide tablets 50, 100mg
For the treatment of adult patients with idiopathic Parkinson's disease (PD) as add- on therapy to a stable dose of Levodopa (L- dopa) alone or in combination with other Parkinson's disease (PD) medicinal products in mid to late stage fluctuating patients.

 

 

09.09.2019

 

 

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