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Latest Articles in usfda

Alembic Pharma Gets USFDA Nod For Formoterol Fumarate Inhalation Solution

The approval for the abbreviated new drug application (ANDA) for formoterol fumarate inhalation solution is for 20 mcg/2 ml per unit-dose vial.

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Sun Pharma Recalls Products In US Market

The US arm of the domestic pharma major is recalling Tadalafil tablets in the American market, according to the latest enforcement report of the USFDA.

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Zydus Cadila Gets USFDA Green Signal For Cancer Drug With 180 Days Exclusivity

The company has received approval from the US Food and Drug Administration (USFDA) for the Nelarabine injection 250 MG/50ML, a generic version of Arranon injection.

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Sun Pharma, Lupin Recall Products In US Market, Says USFDA

New Jersey-based Sun Pharmaceutical Industries Inc, a unit of the company, has initiated the Class III nationwide (US) recall of the 10-count blister packs on October 12 this year.

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USFDA Issues 6 Observations After Inspection Of Biocon's Malaysian Arm Mfng Facility

At the conclusion of the inspection, the agency has issued a Form 483 with a total of 6 observations across Drug Substance, Drug Product and Devices Facilities

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Zydus Cadila Gets USFDA Nod To Market Depression Treatment Drug In US Market

The drug will be manufactured at the group''s formulation manufacturing facility at the SEZ, Ahmedabad, Zydus Cadila noted.

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Zydus Cadila Gets USFDA Nod For Diabetes Medication

Zydus had filed a new drug application (NDA) with the USFDA seeking approval to market Sitagliptin base 25, 50 and 100 mg tablets.

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Zydus Cadila Gets USFDA Nod For Arthritis Drug With 180-Days Exclusivity

Zydus was the first abbreviated new drug application (ANDA) filer on Tofacitinib extended-release tablets 22 mg and thus holds 180-day exclusivity on this strength

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Alembic Pharma Gets Final Approval From USFDA For OCD Treatment Drug

Alembic has a cumulative total of 149 abbreviated new drug application (ANDA) approvals, which includes 131 final approvals and 18 tentative approvals, from USFDA.

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Dr Reddy's Re-Launches Naproxen Sodium OTC Tablets In US Market

Dr Reddys Naproxen Sodium Tablets USP, 220 mg, will be available in multiple-pack sizes to allow consumers a variety of purchasing options.

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Zydus Cadila Gets USFDA Nod For Breast Cancer Treatment Drug

The group now has 320 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.

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AstraZeneca To Apply For Covid-19 Vaccine Approval In US Later In 2021

The timeline for the USFDA application has been in the works since the end-March when AstraZeneca released the data from its clinical trials of the COVID-19 vaccine in the US.

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Alkem Laboratories Says USFDA Inspection At Taloja Facility Ends With 'Zero' Observations

Shares of Alkem Laboratories were trading 0.30 per cent lower at Rs 3,362.05 apiece on BSE.

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Biocon Biologics, Viatris Get USFDA Nod For 1st Interchangeable Biosimilar Insulin Product

The approval for the product, which will allow substitution of Semglee for the reference product, Lantus, at the pharmacy counter, will be introduced before the end of the year

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Sun Pharma, Cassiopea Spa Ink License & Supply Agreements For Acne Treatment Drug Winlevi

The USFDA approved Winlevi (clascoterone cream 1 per cent) in August 2020, for the topical treatment of acne vulgaris in patients 12 years and older.

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