Drug Approval | October 18, 2022
Zydus receives tentative approval from USFDA for Roflumilast tablets
Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data
Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data
Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
Amantadine Extended-Release capsules had annual sales of US $2.7 million in the United States according to IQVIA data
Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of US $2.4 billion in US
The ANDA was filed as 'First to File' submission on NCE-1 date.
Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery
These moves are designed to strengthen the company’s medical and scientific focus and support its continued record growth through closer alignment of all aspects of strategy, sales, and delivery to delight customers
Cariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder
Findings to be featured in a late-breaking proffered paper session at European Society for Medical Oncology (ESMO) Congress 2022
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (RLD Suprep Bowel Prep Kit) had estimated annual sales of US $202 mn in the US
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