Wockhardt recalls 12 drugs in US made at two India units
Wockhardt has decided to voluntarily recall all the remaining batches of 12-15 products that were manufactured in the Chikalthana…
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Browsing Tag
US Food and Drug Administration
US FDA public meeting on June 15 on reauthorisation of GDUFA
FDA has invited public suggestions on the GDUFA programme and the features FDA should propose for the next programme
US FDA nod for generics of Abilify
To market generic aripiprazole in multiple strengths and dosage forms to treat mental disorders
Merck receives FDA Fast Track Designation for Evofosfamide
It will help in treating patients living with advanced pancreatic cancer
DRL, Promius Pharma files NDAs with US FDA
Dr Reddy’s Laboratories and its subsidiary, Promius Pharma announced the filing of three 505(b)(2) New Drug Applications (NDAs)…
DRL and its subsidiary Promius Pharma files three NDAs with US FDA
The three NDAs - DFD-01, DFD-09, and DFN-11, are in support of Dr Reddy’s Proprietary Products group
US FDA, DCG(I) explore more ways to work together
Willing to collaborate with Indian regulators, other stakeholders: US FDA
US FDA approves new antibacterial drug Avycaz
The most common side effects include vomiting, nausea, constipation and anxiety
US FDA raises concerns over Lupin’s plant at Pithampur
FDA inspected the plant in January this year and listed six observations on the manufacturing processes at the plant
Novartis Cosentyx’s first IL-17 inhibitor to receive EU approval
Cosentyx is the only biologic that can be used as first-line systemic therapy in the treatment of psoriasis and as an alternative…