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USFDA

Granules Pharma clears USFDA audit

Granules India yesterday announced that Granules Pharmaceuticals, a wholly-owned foreign subsidiary of the company located in Chantilly, Virginia, USA, has cleared a...
Medicine Tablet

Zydus Cadila gets USFDA nod for Ibrutinib tablets

Zydus Cadila has received tentative approval from the US Food and Drug Administration (USFDA) to market Ibrutinib tablets, in the strengths of...
USFDA

Lupin gets USFDA nod for generic Antifungal drug

Global pharma major Lupin Limited announced the US launch of tavaborole topical solution, 5% having received an approval from the United States...
USFDA

Unichem gets tentative USFDA nod for drug to treat Diabetes

Unichem Laboratories has received tentative approval for ANDA of Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg from the United...
USFDA

Alembic gets USFDA final nod for Erlotinib Tablets

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug...
USFDA

Alembic gets USFDA nod for drug for the treatment of Depression

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug...
USFDA

USFDA approves Abbott’s Stent to treat high bleeding risk patients

Abbott announced its XIENCE family of stents has received US Food and Drug Administration (USFDA) approval for one-month (as short as 28...
USFDA

Zydus Cadila gets USFDA nod for drug to treat HIV infection

Zydus Cadila has received final approval from US Food and Drug Administration (USFDA) to market emtricitabine and tenofovir disoproxil fumarate tablets, 100...
USFDA

Alembic gets USFDA nod for Nitrofurantoin Capsules USP

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug...
USFDA

Axio Biosolution gets USFDA nod for Patch for bleeding control

Axio Biosolutions, an integrated wound care company has received the USFDA 510(k) clearance of its hemostatic product Axiostat Patch, which helps control...
USFDA

Glenmark gets USFDA nod for generic Lung cancer drug

Glenmark Pharmaceuticals yesterday said it has received approval from the US health regulator to market Nintedanib capsules, used in the treatment of...

USFDA okays Tocilizumab for treatment of Covid-19

Washington: The US Food and Drug Administration (USFDA) has issued an emergency use authorisation (EUA) for the drug Actemra (tocilizumab) -- used for arthritis -- for...
Zudus

Zydus Cadila gets tentative nod from USFDA for Pemetrexed for Injection

Zydus Cadila has received tentative approval from the USFDA to market Pemetrexed for Injection in the strengths of 100mg/vial, 500 mg/vial, and...
USFDA

USFDA approves this drug for emergency use for severe C-19

The US health regulators have approved Roche’s arthritis drug Actemra for emergency use to treat hospitalised C-19 patients, giving an extra boost...
Medicine

Cipla gets USFDA nod for Inhalation product

Cipla yesterday said that it has received final approval from the US health regulator for Arformoterol Tartrate Inhalation Solution, used to treat...
USFDA

Zydus Cadila gets tentative nod from USFDA for Fingolimod Capsules

Zydus Cadila has received tentative approval from the United States US (USFDA) to market Fingolimod capsules in the strength of 0.25 mg...
USFDA

Alkem gets two observations from USFDA for USA plant

Alkem Laboratories on Saturday said the US health regulator has issued two observations after inspection of its St Louis-based manufacturing facility. The US Food...
USFDA

Lupin gets USFDA nod for treatment of Kidney patient

Global pharma major Lupin Limited announced that it has received approval for its sevelamer hydrochloride tablets, 400 mg and 800 mg from...
USFDA

Aleor gets USFDA nod for Testosterone Topical Solution

Alembic Pharmaceuticals announced that its joint venture Aleor Dermaceuticals has received final approval from the US Food & Drug Administration (USFDA) for...
USFDA

Avenue Therapeutics gets complete response letter from USFDA for IV Tramadol

Avenue Therapeutics, focused on the development of intravenous (IV) tramadol for the US market, announced that it has received a second Complete...
USFDA

Natco gets USFDA nod for Carfilzomib Injection

Natco Pharma announced that its marketing partner, Breckenridge Pharmaceutical has received approval for its Abbreviated New Drug Application (ANDA) for Carfilzomib Vials...

Zydus Cadila gets tentative USFDA nod for Epilepsy drug

Zydus Cadila has received tentative approval from the USFDA to market Brivaracetam Tablets, in the strengths of 10 mg, 25 mg, 50...
USFDA

Lupin gets warning letter from USFDA for Somerset facility

Drug firm Lupin on Sunday said it has received a warning letter from the US health regulator for its Somerset facility in the US.
USFDA

Lupin gets USFDA nod for generic drug to treat HIV infection

Global pharma major Lupin Limited has received approval for its emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, from the United...

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