US FOOD AND DRUG ADMINISTRATION

Dr Reddy's Laboratories and Sun Pharma are recalling products in the US due to manufacturing issues, as per the latest USFDA Enforcement Report. Dr Reddy's is recalling insomnia and gout drugs, with 13,752 bottles of Eszopiclone tablets affected by ...

Zydus Lifesciences announced on Thursday that it has received tentative approval from the US Food and Drug Administration (USFDA) to market its generic Azilsartan Medoxomil tablets, which are used to treat high blood pressure. The USFDA's tentative ...

Three top American lawmakers have raised concerns about the FDA's foreign drug inspection program in India and China. In a letter to FDA Commissioner Robert Califf, they highlighted inconsistencies in inspection outcomes from January 2014 to April 2...

Drugmakers Lupin and Aurobindo Pharma are recalling products from the American market due to manufacturing issues, as reported by the US Food and Drug Administration (USFDA). Lupin Pharmaceuticals Inc, a US-based unit of Lupin, is specifically recal...

Alembic Pharmaceuticals Ltd received final approval from the US health regulator for generic Dabigatran Etexilate capsules 75 mg and 150 mg to reduce stroke and blood clots in adults with a specific medical condition.

Torrent Pharmaceuticals announced that the US Food and Drug Administration (USFDA) issued a Form 483 with five observations after inspecting its manufacturing plant in Indrad, Gujarat, from June 3 to June 12. The inspection included a pre-approval i...

Indoco Remedies on Thursday said it has received approval from the US health regulator to market a generic diabetes medication. The company has received tentative approval from the US Food and Drug Administration (USFDA) for abbreviated new drug app...

Whole, fresh cucumbers have been recalled by a Florida-based producer as they may be contaminated with salmonella, a gram-negative bacteria, that can cause severe diseases.

Novavax's updated vaccine targets a variant called JN.1, which is in line with European recommendations. The European Union's regulator told vaccine makers last month to update their vaccines for that variant because they would likely be effective a...

Zydus Lifesciences Ltd receives final USFDA approval to market generic Theophylline extended-release tablets of strengths 300 mg and 450 mg for asthma and COPD treatment. The drug will be manufactured at the group's formulation manufacturing facilit...

Strides Pharma Science on Wednesday said its unit has received approval from the US health regulator to market a generic medication used in the treatment of gastrointestinal diseases. Singapore-based Strides Pharma Global Pte. Ltd, has received appr...

Biocon Biologics received US Food and Drug Administration (USFDA) approval for biosimilar Yesafili, a vascular endothelial growth factor inhibitor for various ophthalmology conditions, including age-related macular degeneration. Yesafili is similar ...

The US Food and Drug Administration (FDA) completes inspection of Solara Active Pharma Sciences' API manufacturing facility in Visakhapatnam, Andhra Pradesh, with no observations. Solara confirms compliance with FDA standards. The facility, dedicate...

The company is also recalling another lot of sapropterin dihydrochloride for the same reason, it added. The USFDA said the drug maker initiated the Class I recall in the US on April 8 this year. As per the US health regulator, a Class I recall perta...

New Zealand's food safety regulator to investigate potential contamination in spice products from Indian brands MDH and Everest, following scrutiny in the US, Australia, and Hong Kong for high levels of ethylene oxide, a cancer-causing pesticide. Th...

Zydus Lifesciences Ltd received final approval from the US Food and Drug Administration (USFDA) to market its generic version of Dapsone gel 7.5% for acne treatment. The gel is manufactured at their facility in Ahmedabad. Dapsone gel 7.5% had annual...

A routine current Good Manufacturing Practices (cGMP) inspection was conducted by the USFDA at the company's manufacturing facility at Kurkumbh, Maharashtra from April 29, 2024, to May 8, 2024, Cipla said in a regulatory filing.

Zydus is among the first suppliers to launch the generic version of Mirabegron extended-release tablets (USP 25 mg) in the US market. The company is also preparing to launch the 50 mg tablets in the market. Mirabegron is indicated for the treatment ...

As per the USFDA, a VAI inspection classification indicates that although investigators found and documented objectionable conditions during the inspection, FDA will not take or recommend regulatory or enforcement action because the objectionable co...