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Articles for Regulatory

Sun Pharma Gets USFDA Warning Letter For Halol Facility, Regulator Warns Action

The top US regulator inspected Sun Pharma's Halol facility between April 26 to May 09 in 2022 and found adulterations in drugs. The samples collected for inspection of the drug offered for import in the US and mentioned as (b)(4) capsules in the warning letter failed to meet the specification for dissolution implying that the drug is adulterated, the USFDA said

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FDA Allows Abortion Medicines To Be Sold At Pharmacies In US

The US Food and Drug Administration (FDA) will allow retail pharmacies to offer abortion pills in the United States for the first time, the agency said on Tuesday, even as more states seek to ban medication abortion

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Eugia Pharma Gets USFDA Nod For Generic Anemia Drug

Eugia Pharma's generic drug is expected to be launched by this month. The approved product has an estimated market size of around US$ 46 million for the twelve months ending November 2022, according to IQVIA

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Roche's Lymphoma Therapy Receives Nod From USFDA

The U.S. Food and Drug Administration's approval for Lunsumio was based on an early-to mid-stage study that showed the drug cleared signs of cancer in patients, with most patients responding to the treatment for at least 18 months, the company said late Thursday

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Alembic Gets USFDA Approval For Pregabalin Capsules

The approved sANDA is therapeutically equivalent to the reference listed drug product, Lyrica Capsules, of Upjohn. Pregabalin Capsules are indicated for neuropathic pain, postherpetic neuralgia, and other indications

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Dozee’s Vital Signs Measurement System Gets USFDA Clearance

Dozee’s proprietary contactless sensor sheet is placed under the patient’s mattress to capture micro-vibrations produced by every heartbeat, respiration cycle, and body movement, using ‘Ballistocardiography’

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Lupin Gets USFDA Nod For Generic Seizure Drug

Brivaracetam Tablets are used to treat or control the partial onset of seizures in adults, young children and infants

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FDA Gives Nod To Mirati's Lung Cancer Drug

Mirati said the drug will be sold under the brand name Krazati at a price of $19,750 for a 200 milligram tablet/180-count bottle

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