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Latest Articles in usfda

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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Zydus Cadila Gets Tentative Nod From USFDA To Market Cancer Drug

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

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Caplin Steriles Gets USFDA Nod For Generic Migraine, Cluster Headache Injection

Shares of Caplin Point Laboratories were trading at Rs 690.45 per scrip on BSE, up 0.14 per cent from its previous close.

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Lupin Launches Generic Antifungal Product In US Market

Tavaborole Topical Solution is generic equivalent of Anacor Pharmaceuticals' Kerydin Topical Solution and is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.

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Alembic Pharma Gets USFDA Nod For Cancer Treatment Drug

The tablet in combination with gemcitabine is also indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

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