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  • Gland Pharma gets...

Gland Pharma gets tentative USFDA nod for generic version of Bridion injection

Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2021-10-09T13:14:48+05:30  |  Updated On 9 Oct 2021 7:44 AM GMT
Gland Pharma gets tentative USFDA nod for generic version of Bridion injection

New Delhi: Drug firm Gland Pharma on Friday said it has received a tentative nod from the US health regulator for generic Sugammadex injection, which is indicated for reversing the effects of the muscle relaxants rocuronium bromide and vecuronium bromide given to patients during surgery.The company "has received tentative approval from the United States Food and Drug Administration (USFDA)...

New Delhi: Drug firm Gland Pharma on Friday said it has received a tentative nod from the US health regulator for generic Sugammadex injection, which is indicated for reversing the effects of the muscle relaxants rocuronium bromide and vecuronium bromide given to patients during surgery.

The company "has received tentative approval from the United States Food and Drug Administration (USFDA) for Sugammadex injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vial...", Gland Pharma said in a regulatory filing.

Also Read:FDA approves Bridion to reverse effects of neuromuscular blocking drugs

The product is the generic version of Merck Sharp & Dohme Corp's Bridion injection, 100 mg/mL, it added.

The company will launch the product through its marketing partner on receipt of final approval, Gland Pharma said.

According to IQVIA, the Sugammadex injection, 200 mg/2 mL and 500 mg/5 mL single-dose vial had US sales of about USD 615 million for 12 months ended April 2021, it added.

Sugammadex injection is used to reverse the effects of the muscle relaxants rocuronium bromide and vecuronium bromide given to patients during surgery, the filing said.

Also Read:Sputnik V production to go fully on stream in September in India, says RDIF

Gland Pharma gland pharma news usfda Sugammadex injection Sugammadex merck bridion injection 
Source : PTI
Medical Dialogues Bureau
Medical Dialogues Bureau

    Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in.

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