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 is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and frequency
Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery
Cariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder
The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad
Nelarabine is in a class of medications called antimetabolites
The group now has 324 approvals and has so far filed over 400 ANDAs
Zydus' Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
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