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Tag: usfda

You Searched For "usfda"
Alembic Pharma bags USFDA okay for Atrial fibrillation drug Dronedarone

Alembic Pharma bags USFDA okay for Atrial fibrillation drug Dronedarone

Ruchika Sharma11 Jan 2022 11:17 AM IST
Vadodara: Drug maker, Alembic Pharmaceuticals Limited, has recently announced that the company has received tentative approval from the US Food &...
Alembic Pharma gets tentative USFDA approval for depressive disorder drug

Alembic Pharma gets tentative USFDA approval for depressive disorder drug

Medical Dialogues Bureau10 Jan 2022 2:30 PM IST
New Delhi: Alembic Pharmaceuticals Ltd on Friday said it has received tentative approval from the US health regulator for its generic Vortioxetine...
Alembic Pharma receives USFDA Final Approval for Entacapone Tablets USP, 200 mg

Alembic Pharma receives USFDA Final Approval for Entacapone Tablets USP, 200 mg

Medical Dialogues Bureau6 Jan 2022 3:27 PM IST
Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration...
Pfizer COVID booster shot for 12 to 15-year-olds backed by USFDA

Pfizer COVID booster shot for 12 to 15-year-olds backed by USFDA

Medical Dialogues Bureau4 Jan 2022 9:45 AM IST
The regulatory decisions come as COVID cases surge due to the Omicron variant, with health authorities warning that its high transmissibility could...
Alembic Pharma Doxycycline Hyclate Delayed-Release Tablets get USFDA okay

Alembic Pharma Doxycycline Hyclate Delayed-Release Tablets get USFDA okay

Medical Dialogues Bureau4 Jan 2022 9:30 AM IST
The approved Doxycycline Hyclate delayed release tablets are therapeutically equivalent to the reference listed drug product (RLD) Doryx Tablets, 75...
Interval between Moderna COVID vaccine 2nd shot, booster still 6 months: USFDA

Interval between Moderna COVID vaccine 2nd shot, booster still 6 months: USFDA

Medical Dialogues Bureau4 Jan 2022 9:30 AM IST
Washington: The interval between receiving a second dose of Moderna's COVID-19 vaccine and a booster dose remains unchanged at six months, U.S. Food...
Can DCGI approved Molnupiravir bolster Indias fight against COVID?

Can DCGI approved Molnupiravir bolster India's fight against COVID?

Farhat Nasim3 Jan 2022 11:45 PM IST
New Delhi: As countries prepare themselves to fight a possible 'next wave'. The new variant – Omicron has been making headline and a surge in Covid-19...
Xeris Biopharma gets USFDA approval for  Endogenous Hypercortisolemia drug Recorlev

Xeris Biopharma gets USFDA approval for Endogenous Hypercortisolemia drug Recorlev

Ruchika Sharma3 Jan 2022 11:00 AM IST
ChicagoXeris Biopharma Holdings, Inc. has announced the U.S. Food and Drug Administration (FDA) approval of Recorlev (levoketoconazole) for the...
Zydus Pharma bags USFDA nod for Pimavanserin Capsules

Zydus Pharma bags USFDA nod for Pimavanserin Capsules

Ruchika Sharma1 Jan 2022 11:15 AM IST
Ahmedabad: Zydus Cadila's U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the US Food and Drug Administration...
Novavax files data with USFDA to back COVID vaccine

Novavax files data with USFDA to back COVID vaccine

Ruchika Sharma1 Jan 2022 10:00 AM IST
Gaithersburg: Novavax, Inc. has announced that the company has completed submission of the final data package, including the complete chemistry,...
First: Beximco Pharma launches generic version of Pfizer Paxlovid for COVID treatment

First: Beximco Pharma launches generic version of Pfizer Paxlovid for COVID treatment

Ruchika Sharma31 Dec 2021 3:26 PM IST
The company will market the product under the brand name Bexovid.
Granules Pharma Amphetamine Mixed Salts gets USFDA okay to treat ADHD, narcolepsy

Granules Pharma Amphetamine Mixed Salts gets USFDA okay to treat ADHD, narcolepsy

Ruchika Sharma31 Dec 2021 12:00 PM IST
Hyderabad: Granules India Limited has recently announced that the US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug...
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