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Mallinckrodt obtains FDA approval for StrataGraft to treat thermal burns pharmaceutical-business-review
June 17, 2021
Mallinckrodt has received the US Food and Drug Administration (FDA) approval for StrataGraft to treat thermal burns with intact dermal elements in adults.
Janssen COVID-19 Vaccine – one regulator blocks use, another promotes it europeanpharmaceuticalreview
June 16, 2021
EU recommends that batches of Janssen COVID-19 Vaccine not be released for use due to a cross contamination report, while the FDA authorises use of drug substance from the facility where the contamination occurred.
Changes to the Mavyret Product Label for Pediatrics americanpharmaceuticalreview
June 16, 2021
The FDA has approved Mavyret (glecaprevir and pibrentasvir) oral pellets (100mg/40mg) for the treatment of pediatric patients 3 to less than 12 years of age weighing less than 45 kg with chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection ...
FDA Takes Steps to Increase Availability of the Janssen COVID-19 Vaccine americanpharmaceuticalreview
June 16, 2021
Following careful review and deliberation, the U.S. FDA is taking important steps that will allow a critically needed supply of the Janssen (Johnson & Johnson) COVID-19 Vaccine to be made available.
Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test - FDA MedWatch americanpharmaceuticalreview
June 16, 2021
The U.S. FDA issued a safety communication warning the public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use.
Avenue Therapeutics gets complete response letter from USFDA for IV Tramadol expresspharma
June 16, 2021
Avenue Therapeutics, focused on the development of intravenous (IV) tramadol for the US market, announced that it has received a second Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its New Drug Application ...
Lupin gets warning letter from US FDA for Somerset facility expresspharma
June 16, 2021
The US FDA had inspected the Lupin Somerset site from September 10, 2020, to November 5, 2020.
Zydus Cadila gets tentative US FDA approval for Brivaracetam tablets expresspharma
June 16, 2021
Zydus Cadila has received tentative approval from the USFDA to market Brivaracetam Tablets, in the strengths of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg (US RLD: Briviact Tablets). Brivaracetam is used to treat partial-onset of seizures (epilepsy).
FDA authorises J&J Covid-19 vaccine substance made at Emergent’s plant pharmaceutical-technology
June 15, 2021
The US Food and Drug Administration (FDA) has approved, under the emergency use authorization (EUA), two batches of Johnson & Johnson (J&J) subsidiary Janssen’s Covid-19 vaccine drug substance produced at the Emergent BioSolutions’ plant in Baltimore, US.
Ocugen to seek full approval for Bharat Biotech’s Covaxin in the US pharmaceutical-technology
June 15, 2021
Ocugen has plans to seek full approval for Bharat Biotech’s Covid-19 vaccine candidate, Covaxin, in the US, after the Food and Drug Administration (FDA) declined to grant an Emergency Use Authorization (EUA).

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