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Latest Articles in usfda
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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Alembic Pharmaceuticals Gets USFDA Nod For Anti-Depressant Drug
Quoting IQVIA data, Alembic Pharma said Desipramine Hydrochloride Tablets have an estimated market size of USD 7 million for twelve months ending March 2021.
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Lupin Arm Gets Supplemental New Drug Application Approval From USFDA For Solosec
Shares of Lupin Ltd closed at Rs 1,146.25 per scrip on BSE, down 0.26 per cent from its previous close.
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