Glenmark Pharma Receives FDA Approval for Anti-Psychotic Tablets

Glenmark Pharmaceuticals Ltd. announced today that it has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Prolixin (fluphenazine hydrochloride) tablets in four strengths – 1 mg, 2.5 mg, 5 mg, and 10 mg. Glenmark’s fluphenazine hydrochloride tablets are the generic version of Prolixin tablets from Apothecon Inc. […]

Glenmark, Cipla get US nod for inhaler drug

Indian pharmaceutical manufacturers Cipla and Glenmark Pharma said they received approval from the US Food and Drug Administration to launch a generic version of Sunovion Pharma’s inhaler therapy Brovana. The drug has substantial sales in the US of around $438 million in the 15 mcg dose and is approved for long-term, twice daily usage for […]

Glenmark says Favipiravir trial shows 29% faster recovery in COVID-19

Glenmark Pharmaceuticals Ltd said its trial of Favirpiravir showed a 28.6% faster recovery among those treated with the antiviral drug than on those who were on standard therapy. The 150-person trial showed “numerical improvements for the primary efficacy endpoint with 28.6% faster viral clearance in the overall population as measured by the median time until […]

Glenmark to distribute Novartis drug in Brazil

India’s Glenmark Pharmaceuticals Ltd said it entered into an exclusive marketing agreement with Novartis Biosciences S.A, a subsidiary of Novartis AG, for three products meant for treating chronic obstructive pulmonary disease (COPD) in Brazil. Under the terms of the agreement, Novartis remains the holder of the registration of these medicines and will be responsible to […]

Glenmark gets tentative US approval for Mylan’s acne cream

Glenmark Pharmaceuticals said it received tentative approval from the United States Food & Drug Administration for a generic version of Mylan Pharma’s acne cream Evoclin. According to IQVIATM sales data, the EVOCLIN Foam 1% has sales of $17.0 million per year in the US. EVOCLIN Foam is indicated for topical application in the treatment of […]

Glenmark Pharmaceuticals gets USFDA nod for sales of stomach relief capsules

Mumbai-based pharmaceutical firm Glenmark Pharmaceuticals said it received final approval from the United States Food and Drug Administration (USFDA) for sales of a generic equivalent of AstraZeneca Pharmaceuticals’ Nexium-Delayed Release capsules. Esomeprazole magnesium capsules are used to treat certain stomach and esophagus problems such as acid reflux and ulcers. It relieves symptoms such as heartburn, […]

Glenmark receives nod from Russia for allergy spray

Mumbai-based pharmaceutical firm Glenmark Pharmaceuticals said it received approval from the Russian Health Ministry for the sales of Momate Rhino, also called Mometasone Furoate metered nasal spray, as an over-the-counter (OTC) drug. Over-the-counter drugs are medicines sold directly to a consumer without prescription from a healthcare professional, as opposed to prescription drugs, which may be […]

Glenmark Pharmaceuticals gets USFDA nod for sales of acne gel

Mumbai-based pharmaceutical firm Glenmark Pharmaceuticals said it received final approval from the US Food and Administration (USFDA) for the sale of a generic version of Valeant Bermuda’s acne treatment, BenzaClin. Clindamycin and benzoyl peroxide gel is a combination of clindamycin, an antibiotic and benzoyl peroxide, an antiseptic. The gel is mainly used on the skin […]

Glenmark reports progress in its eczema drug investigation

Glenmark Pharmaceuticals, a pharmaceutical company headquartered in Mumbai, reported progress in a proof-of-concept study of GBR 830, being studied as a treatment for atopic dermatitis, commonly known as eczema. The company said it was able to notice a decline in atopic dermatitis score during the study involving 62 patients, which also showed that the drug […]

Glenmark Pharma gets USFDA approval for generic cholesterol drug

Glenmark Pharmaceuticals said received approval from the United States Food & Drug Administration to sell cholesterol-lowering drug Colesevelam Hydrochloride in the country. The approval is for two packet sizes – 1.875 grams and 3.75 grams. Colesevelam Hydrochloride is the generic version of Daiichi Sankyo’s oral suspension Welchol. Welchol had annual sales of approximately $73.0 million for […]

Glenmark Pharma gets UDFDA nod for first generic out of US facility

Glenmark Pharmaceuticals received a boost for its plans to manufacture drugs within the US, with the FDA approving the first generic manufacturing application from the facility. The FDA approved the manufacturing of Atovaquone and Proguanil Hydrochloride Tablets at its Monroe, North Carolina facility via a supplementary ANDA (drug application). “This approval is an important milestone for our […]

Glenmark reveals encouraging data from hay fever study

Glenmark Pharmaceuticals reported encouraging clinical trial data from the study of its drug Ryaltris for hay fever or seasonal allergic rhinits. “Results of these robust studies demonstrates that consistent, significant relief from symptoms may be rapidly achieved and sustained with Ryaltris,” said Frank Hampel, Principal Investigator, Central Texas Health Research. “These findings, combined with prior […]

Glenmark to market South Korean co’s drugs in the US

Glenmark Pharmaceuticals, a global pharmaceutical company based in India, said it has signed an exclusive agreement with a South Korean company to sell six eye-related generic drugs in the US market. The total U.S. brand sales for the six products was approximately $1.7 billion for calendar year 2017. Glenmark said it expects to file six […]

Glenmark Pharma finds encouraging results from skin drug trial

Glenmark Pharmaceuticals reported encouraging results from its Phase 2 clinical trial for GBR 830, a drug that it is testing as a potential treatment for a skin disease known as atopic dermatitis. “A clinical improvement in Eczema Area and Severity Index (EASI) scores was observed in 17 out of 23 patients treated with GBR 830,” […]

Glenmark launches anti-inflammation drug based on Adalimumab

Glenmark Pharmaceuticals said it has launched a biosimilar of Adalimumab, a drug for Plaque Psoriasis and Rheumatoid Arthritis from Cadila Healthcare Ltd.. “The launch of ADALY marks the launch of Glenmark’s first biosimilar in Dermatology,” the company said. The drug has been licensed from Cadila. “ADALY will be available to patients in India at a […]

Glenmark reports successful trial for nasal spray, to file NDA soon

Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that its nasal spray Ryaltris met safety and efficacy goals in a Phase 3 clinical study in treating perennial allergic rhinitis. With the positive results, the company said it plans to submit an application to the USFDA for treating seasonal allergic rhinitis in the first quarter of […]