The approved product is therapeutically equivalent to the reference listed drug Optivar Ophthalmic Solution of Mylan Specialty L P.
Jubilant Life Sciences in a regulatory filing said it has been informed by the US Food and Drug Administration (USFDA) that inspection from December 10-18, 2018 at the Jubilant Generics Ltd API manufacturing facility, in Nanjangud, Mysore, has been classified as 'Official Action Indicated' (OAI).
The company has received the final approval from the United States Food and Drug Administration (USFDA) to market generic Acyclovir ointment USP 5 per cent, Zydus Cadila said in a filing to the BSE.
The company is a fully-owned subsidiary of Cadista Holdings Inc, which is a part of the Noida-based Jubilant Life Sciences Company.
Lupin said the company does not believe that this classification will have an impact on disruption of supplies or the existing revenues from operations of this facility.
Scott Gottlieb, the chief of the US Food & Drug Administration, announced he will be stepping down next month.
"The United States Food and Drug Administration (USFDA) may withhold approval of any new applications or supplements till the company addresses all issues raised by the agency," Jubilant Life Sciences said in a filing to the BSE.
Actions by the US drug regulator impacts Indian manufacturers, who generate significant revenue by selling copycat drugs at a fraction of the cost in the world's largest market for medicines
'The inspection at the Bengaluru facility took place between February 25-March 5, resulting in a Form 483 with six observations,' it added.
The company has received approval from the United States Food and Drug Administration to market its Rivastigmine transdermal system 4.6 mg/24 hrs, 9.5 mg/24 hrs and 13.3 mg/24 hrs.
The approved products is a generic version of Boehringer Ingelheim Pharmaceuticals Inc's Micardis HCT tablets.
According to USFDA data, out of 174 inspections in 2018 only 4 percent inspections are classified as OAI, attracting agency’s regulatory and administrative action such as withholding new approvals, warning letter and import alert, in contrast to 15 percent in 2017.
The company has received US Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA), Gemcitabine for injection USP in the strengths of 200 mg/vial and 1 g/vial, Shilpa Medicare said in a BSE filing.
In a regulatory filing Dr Reddy's said, "The audit of our formulations Shreveport plant, Louisiana, USA, by the United States Food and Drug Administration (USFDA) has been completed with zero observations".
The company has received final approval from the United States Food and Drug Adminstration (USFDA) to market generic Phytonadione tablets USP in the strength of 5 mg, Zydus Cadila said in a statement.
The approval has been granted by the USFDA to Glenmark Pharmaceuticals, US, for clobetasol propionate foam, 0.05 percent, a generic version of Olux Foam, 0.05 percent, of Mylan Pharmaceuticals, the company said in a statement.
The approved product is therapeutically equivalent to the reference listed drug product Vigamox Ophthalmic Solution USP, 0.5 per cent, of Novartis Pharmaceuticals Corporation.
The company has received approval from the US Food and Drug Administration to market the drug in the strength of 37.5 mg/25 mg.
"Glenmark Pharmaceuticals Inc, USA (Glenmark) has been granted final approval by the United States Food and Drug Administration (USFDA) for Sevelamer Hydrochloride tablets in the strengths of 400 mg and 800 mg," the company said in a BSE filing.
Carbamazepine is an anticonvulsant agent. It works by reducing excessive nerve signals in the brain and restoring the normal balance of nerve activity.
According to a statement issued by the drug maker, 'Tosymra' (previously known as DFN-02), is the latest product to join the Dr Reddy's US subsidiary Promius Pharma's acute migraine treatment portfolio.
The product will be manufactured at the group's formulations manufacturing facility at a special economic zone in Ahmedabad.
"The audit of our formulations Srikakulum Plant (SEZ) Unit I, Andhra Pradesh by the US Food and Drug Administration (USFDA), has been completed today. We have been issued a Form 483 with 4 observations, which we are addressing," the Hyderabad-based company said in a regulatory filing.
Zydus Cadila has received the approval from the United States Food and Drug Administration (USFDA) to market the drug in the strengths of 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, the company said in a BSE filing.
The approval from the United States Food and Drug Administration (USFDA) is for the company's abbreviated new drug application (ANDA) for Pramipexole Dihydrochloride extended-release tablets, in the strengths of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, and 4.5 mg, Alembic Pharmaceuticals said in a filing to BSE.