Tag: USFDA

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» 2019-05-23

Pharmaceutical manufacturer Zydus Cadila said that it received final approval from the United States Food and Drug Administration (USFDA) for the sales of a generic equivalent of Nexium Delayed-Release capsules […]

» 2019-05-22

Pharmaceutical major Lupin said it launched the asthma drug Budesonide Inhalation Suspension ampules in the US market.   Budesonide Inhalation Suspension ampules are a generic equivalent of Pulmicort Respules Inhalation […]

» 2019-05-21

Alembic Pharmaceuticals Ltd said it received final approval from the United States Food and Drug Administration for the sales of a therapeutic equivalent of Vesicare tablets manufactured by Astellas Pharma […]

» 2019-05-15

Pharmaceutical firm Dr Reddy’s Laboratories Ltd said it has launched Daptomycin antibiotic in the US market. Daptomycin is used alone or in combination with other medications to treat certain blood […]

» 2019-05-14

Pharmaceutical major Lupin said that the United States Food and Drug Administration (USFDA) has given it an Establishment Inspection Report (EIR) for its Mumbai-based global  pharmacovigilance group, Drug Safety & […]

» 2019-05-14

Mumbai-based pharmaceutical firm Glenmark Pharmaceuticals said it received final approval from the United States Food and Drug Administration (USFDA) for sales of a generic equivalent of AstraZeneca Pharmaceuticals’ Nexium-Delayed Release […]

» 2019-05-13

Pharmaceutical manufacturer Zydus Cadila said it received the final approval for sales of a generic equivalent of Pfizer’s Thalitone tablets. Chlorthalidone tablets are used for the treatment of high blood […]

» 2019-05-10

Pharmaceutical major Lupin announced the launch of a generic equivalent of Lundbeck Pharms’ Onfi tablets in the US market. Clobazam is used to control seizures in adults and children 2 […]

» 2019-05-07

Pharmaceutical major Lupin said that it received tentative approval from the United States Food and Drug Administration for the sales of a generic equivalent of Merck Sharp & Dohme Corp’s […]

» 2019-05-07

Pharmaceutical company Unichem Laboratories said it received a tentative approval from the United States Food and Drug Administration (USFDA) to sell a generic equivalent of Johnson and Johnson Consumer Inc’s […]

» 2019-05-06

Alembic Pharmaceuticals said one of its dermatology-focused joint ventures, Aleor Dermaceuticals Ltd, received an Inspection Report for its formulation facility at Karakhadi, Gujarat from the United States Food and Drug […]

» 2019-05-06

Hyderabad-headquartered Dr Reddy’s Laboratories said it has launched a therapeutic equivalent of AbbVie Inc’s AndroGel in the US market, a month after rival Lupin did so. Testosterone Gel is used […]

» 2019-05-03

Pharmaceutical manufacturer Zydus Cadila said that the United States Food and Drug Administration has issued 14 observations after an inspection at its manufacturing facility at Moraiya, Ahmedabad. Observations indicate that […]

» 2019-05-03

Pharmaceutical major Cipla and its subsidiary Cipla USA announced the phased launch of a generic therapeutic equivalent version of Sensipar, a branded drug manufactured by Amgen Inc. The launch, however, […]

» 2019-04-30

Pharmaceutical manufacturer Zydus Cadila said it received approval from the United States Food and Drug Administration for the sales of a generic version of Valeant Pharmaceuticals’ Syprine capsules and a […]

» 2019-04-26

Ahmedabad-based Torrent Pharmaceuticals said its manufacturing facility at Indrad in Gujarat was subject to certain ‘procedural observations’ by the United States Food and Drug Administration following a routine inspection. The […]

» 2019-04-25

Pharmaceutical manufacturer Zydus Cadila said it received final approval from the United States Food and Drug Administration for sales of a generic version of Aventis Pharma’s Arava tablets. Leflunomide tablets, […]

» 2019-04-22

Alembic Pharmaceuticals said it received approvals from the United States Food and Drug Administration (USFDA) for sales of a therapeutic equivalent of French pharma major Sanofi Aventis’ Aubagio tablets and […]

» 2019-04-18

Pharmaceutical manufacturer Granules India Ltd said that it has received approval from the United States Food and Drug Administration to sell a bioequivalent version of Johnson & Johnson’s Tylenol tablets. […]

» 2019-04-12

Pharmaceutical major Lupin said that it has launched a generic equivalent of AbbVie Inc’s AndroGel, a a day after it received approval for its sales from the United States Food […]

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