Zydus receives final and tentative approval from USFDA for Tofacitinib Tablets
Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)
Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)
Cipla has received 8 inspectional observations in Form 483
Canagliflozin and Metformin Hydrochloride Tablets had annual sales of US $49.4 million in the United States
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India
Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States.
The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India
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
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