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Latest Articles in usfda

Alembic Pharma JV Aleor Dermaceuticals Gets USFDA Nod For Testosterone Topical Solution

Aleor is a 60:40 joint venture between Alembic and Orbicular Pharmaceutical Technologies Pvt Ltd (Orbicular), focusing on commercialising dermatology products globally.

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Dr Reddy's Ordered To Pay USD 46.25 Mn To Hatchtech

Dr Reddy's had announced the receipt of an approval of XEGLYZE under the NDA (new drug application) category from the US Food and Drug Administration (USFDA).

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Avenue Therapeutics Gets Second Complete Response Letter From USFDA For Intravenous Tramadol

The CRL stated that the delayed and unpredictable onset of analgesia with intravenous tramadol does not support its benefit as a monotherapy to treat patients in acute pain

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Natco Pharma's Marketing Partner Gets USFDA Nod For Anti-Cancer Drug

Natco Pharma said based on the ANDA filing date, the company believes that it is eligible for 180 days of sole generic marketing exclusivity for the 10 mg strength and shared 180 days of generic marketing exclusivity for the 60 mg strength of the product at the time of launch.

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Zydus Cadila Gets USFDA Tentative Nod For Epilepsy Treatment Drug

The group now has 319 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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Lupin Gets Warning Letter From USFDA For Somerset Facility

Lupin is committed to addressing the concerns raised by the USFDA and will work with the FDA and the New Jersey district to resolve these issues at the earliest

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Mankind Pharma Launches Drug To Treat Black Fungus

The antifungal drug with minimal potential for nephrotoxicity and excellent tolerability profile has been cleared by the USFDA.

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Zydus Cadila Gets Tentative USFDA Nod To Market Lung Cancer Treatment Drug

The group now has 318 approvals and has so far filed over 400 abbreviated new drug applications since the commencement of the filing process in financial year 2003-04.

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Glenmark Pharma Launches Anti-Epileptic Drug In US

Banzel tablets are used in combination with other medications to treat children with Lennox-Gastaut syndrome, a severe form of childhood epilepsy that also causes developmental and behavior problems.

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Glenmark Pharma Gets USFDA Nod For Icatibant Injection

The drug firm said its current portfolio consists of 172 products authorised for distribution in the US marketplace and 44 abbreviated new drug applications are pending approval with the USFDA.

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Sun Pharma Recalls 50,868 Bottles Of Diabetes Drug In US

The US-based arm of the drug firm is recalling the affected lot of 500 mg tablets (in 500 count bottles) due to 'presence of foreign substance identified as activated carbon', as per the latest Enforcement Report issued by the US health regulator.

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Alembic Pharma Gets USFDA Nod For Bipolar Depression Drug

Alembic Pharma said Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg have an estimated market size of USD 3.7 billion for the twelve months ending December 2020.

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Alembic Pharma Gets USFDA Nod For Ophthalmic Solution

Alembic Pharma said Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2 per cent and 0.5 per cent has an estimated market size of USD 80 million for twelve months ending December 2020.

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Lupin, Sun Pharma, Jubilant Cadista Recall Drugs In US Market

The affected lot has been produced by Jubilant Generics at its Roorkee based plant in Uttarakhand and marketed in the US by Salisbury-based Jubilant Cadista Pharmaceuticals, Inc.

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Zydus Cadila Gets USFDA Nod To Market Anti-Arrhythmic Drug

Shares of Cadila Healthcare were trading 1.18 per cent higher at Rs 558.75 apiece on BSE.

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