Drug Approval | October 27, 2022
Zydus gets USFDA’s approval for Ketorolac Tromethamine Tablets
Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.
Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 112 million in the U.S. (IQVIA MAT August 2022).
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of US $112 million in the US
Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data
The need for hot-melt extrusion (HME) polymers is expected to grow as the pharma industry moves to implement more continuous and sustainable processes.
Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
The product will be manufactured at Lupin's facility in Nagpur, India.
Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and frequency
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.
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