Glenmark Pharmaceuticals announced positive results for GSP 301, (mometasone furoate (25 mcg) and olopatadine hydrochloride (665 mcg)) administered twice-daily as...
Glenmark Pharmaceuticals announced results from new analyses of pooled data from clinical studies of Ryaltris (olopatadine hydrochloride and mometasone furoate...
Glenmark Pharmaceuticals announced the launch of antiviral drug FabiFlu (favipiravir) for the treatment of mild to moderate COVID-19 patients.
Glenmark announced Phase III results that showed its antiviral treatment favipiravir demonstrated a 28.6% faster viral clearance of COVID-19 compared to placebo.
Treatment of HIV-1 infection: Emtricitabine/Tenofovir disoproxil Glenmark is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1). Emtricitabine/Tenofovir disoproxil Glenmark is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents (see sections 4.2, 4.4 and 5.1).
Bausch Health Companies Inc. and Glenmark Specialty S.A., a subsidiary of Glenmark Pharmaceuticals Ltd. announce that Ryaltris (olopatadine hydrochloride and mometasone furoate nasal spray) has been approved by Health Canada for the symptomatic treatment of moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults, adolescents, and children aged 6 years and older
Atovaquone Glenmark 750 mg/5 ml oral suspension is indicated for: Acute treatment of mild to moderate Pneumocystis pneumonia (PCP, caused by Pneumocystis jiroveci, formerly classified as P. carinii) (alveolar - arterial oxygen tension difference [(A-a) DO2] < 45 mmHg (6 kPa) and oxygen tension in arterial blood (PaO2) ≥ 60 mmHg (8 kPa) breathing room air) in patients who are intolerant of co-trimoxazole therapy (see section 4.4).
Non-Small Cell Lung Cancer (NSCLC): Erlotinib Glenmark is indicated for the first-line treatment of patients with locally advanced or metastatic non- small cell lung cancer (NSCLC) with EGFR activating mutations. Erlotinib Glenmark is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy. Erlotinib Glenmark is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. In patients with tumours without EGFR activating mutations, Erlotinib Glenmark is indicated when other treatment options are not considered suitable. When prescribing Erlotinib Glenmark, factors associated with prolonged survival should be taken into account. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC negative tumours (see section 5.1). Pancreatic cancer: Erlotinib Glenmark in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer. When prescribing Erlotinib Glenmark, factors associated with prolonged survival should be taken into account (see sections 4.2 and 5.1). No survival advantage could be shown for patients with locally advanced disease.
Efavirenz/Emtricitabine/Tenofovir disoproxil Glenmark is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate. It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Efavirenz/Emtricitabine/Tenofovir disoproxil Glenmark prior to initiation of their first antiretroviral treatment regimen (see sections 4.4 and 5.1). The demonstration of the benefit of efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavirenz/emtricitabine/tenofovir disoproxil (see section 5.1). No data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients. No data are available to support the combination of Efavirenz/Emtricitabine/Tenofovir disoproxil Glenmark and other antiretroviral agents.
