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Articles for Regulatory

USFDA Backs Otsuka's BP Treatment Device

The FDA panel backed the use of the device made by the Japanese company's unit ReCor for renal denervation, which is indicated for use in patients whose hypertension, or high blood pressure, cannot be controlled with drug

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Glenmark Pharma Gets ANDA Approval For Tacrolimus Ointment

The drug is indicated to treat moderate to severe atopic dermatitis in people who have got other medicines but did not benefit. Atopic dermatitis is a skin condition which causes itching, redness, and inflammation

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Aurobindo Pharma Gets USFDA Approval For Hereditary Angioedema Drug

Aurobindo Pharma on Wednesday said that its wholly-owned subsidiary company, Eugia Pharma specialities has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Icatibant Injection, 30 mg/3 mL (10 mg/mL)

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Lupin Gets Nod For Blood Pressure Drug From USFDA

Indian pharma major Lupin on Wednesday said that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Metoprolol Succinate Extended-Release Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg, to market a generic equivalent of Toprol-XL Tablets of Sequel Therapeutics, LLC

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Lupin Gets USFDA Nod For Doxycycline Hyclate Delayed-Release Tablets

Known as a tetracycline antibiotic Doxycycline Hyclate Tablets are used to treat a wide variety of bacterial infections, subsuming those that cause acne

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Lupin’s Mandideep Unit-2 Facility Completes USFDA Inspection With Zero Observations

The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations

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USFDA Approves Johnson & Johnson's Blood Cancer Therapy

Johnson & Johnson said on Thursday the U.S. Food and Drug Administration had approved its antibody-based therapy for patients with a difficult-to-treat type of blood cancer

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Lupin Gets USFDA Approval For Fluocinolone Acetonide Body Oil

Fluocinolone Acetonide Oil is indicated to relieve redness, itching, swelling, or other discomfort caused by skin conditions

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