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    • USFDA approval

    Tag: usfda approval

    You Searched For "USFDA approval"
    Novo Nordisk wins USFDA nod for oral diabetes drug Rybelsus

    Novo Nordisk wins USFDA nod for oral diabetes drug Rybelsus

    Medical Dialogues Bureau23 Sept 2019 2:16 PM IST
    Novo Nordisk did not disclose what it plans to charge for the new oral treatment, called Rybelsus, but said it would be "competitively priced" with...
    Dr Reddys unveils generic version of Zyban ER tablets in US

    Dr Reddys unveils generic version of Zyban ER tablets in US

    Medical Dialogues Bureau5 Sept 2019 5:01 PM IST
    The company has launched Bupropion hydrochloride extended-release tablets USP (SR), approved by the United States Food and Drug Administration...
    Lupin gets USFDA approval for generic version of Westcort cream to treat skin conditions

    Lupin gets USFDA approval for generic version of Westcort cream to treat skin conditions

    Farhat Nasim18 Aug 2019 9:46 AM IST
    Hydrocortisone Valerate cream is a generic version of Sun Pharmaceutical Industries Ltd's Westcort cream in the same strength, Lupin added.New Delhi:...
    Morepen Labs Q1 export sale of Atorvastatin Calcium up by 57 percent

    Morepen Labs Q1 export sale of Atorvastatin Calcium up by 57 percent

    Medical Dialogues Bureau17 Aug 2019 9:13 AM IST
    Morepen Labs' export sales in Q1'FY 2019-20 for Montelukast Sodium rose by 210 per cent and that of Atorvastatin Calcium by 57 per cent vis-a-vis the...
    Sun Pharma records Total Revenue of Rs 8374.36 crore for June quarter

    Sun Pharma records Total Revenue of Rs 8374.36 crore for June quarter

    Medical Dialogues Bureau16 Aug 2019 9:30 AM IST
    Mumbai: India's largest drugmaker Sun Pharmaceutical Industries Ltd. (Sun Pharma) recently reported a consolidated net profit of Rs 1,387.48 crore...
    Zydus Cadila wins USFDA nod for Minocycline Hydrochloride ER tablets to treat acne

    Zydus Cadila wins USFDA nod for Minocycline Hydrochloride ER tablets to treat acne

    Medical Dialogues Bureau3 Aug 2019 9:45 AM IST
    Minocycline hydrochloride extended-release tablets are indicated to treat only inflammatory lesions of non-modular moderate to severe acne vulgaris in...
    Alembic Pharma gets USFDA nod for Bromfenac Ophthalmic Solution

    Alembic Pharma gets USFDA nod for Bromfenac Ophthalmic Solution

    Farhat Nasim24 Jun 2019 12:25 PM IST
    The approved product, Bromfenac Ophthalmic Solution is therapeutically equivalent to the reference listed drug (RLD), Bromday Ophthalmic Solution,...
    Roche gets USFDA nod for combo lymphoma treatment Polivy

    Roche gets USFDA nod for combo lymphoma treatment Polivy

    Medical Dialogues Bureau11 Jun 2019 9:30 AM IST
    Polivy was approved in combination with Roche's older drug Rituxan and a chemotherapy agent for adult patients with advanced diffuse large B-cell...
    Panacea Biotec gets USFDA nod for chemotherapy drug Azacitidine

    Panacea Biotec gets USFDA nod for chemotherapy drug Azacitidine

    Farhat Nasim22 May 2019 9:45 AM IST
    Azacitidine is a chemotherapy drug used to treat myelodysplastic syndromes (MDS) with annual sales of about USD 110 million in US markets as per IQVIA...
    Zydus Cadila gets tentative USFDA nod to Tofacitinib tablets for treating arthritis

    Zydus Cadila gets tentative USFDA nod to Tofacitinib tablets for treating arthritis

    Farhat Nasim6 April 2019 3:00 PM IST
    Tofacitinib is used alone or with other medications to treat moderate to severe forms of rheumatoid arthritis, the company said in a BSE filing. New...
    Lupin gets USFDA nod to Methylprednisolone tablets to treat inflammation

    Lupin gets USFDA nod to Methylprednisolone tablets to treat inflammation

    Farhat Nasim26 Feb 2019 9:50 AM IST
    The company has received approval from the US Food and Drug Administration (USFDA) to market Methylprednisolone tablets, a generic version of...
    Pfizer gets USFDA approval for second biosimilar of Remicade

    Pfizer gets USFDA approval for second biosimilar of Remicade

    Ruby Khatun Khatun18 Dec 2017 10:15 AM IST
    The U.S. Food and Drug Administration approved Pfizer Inc's second biosimilar to Johnson and Johnson's blockbuster rheumatoid arthritis drug,...
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