In conjunction with the launch, the company said it has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Desvenlafaxine Extended-release
Tablets, which is indicated for the treatment of major depressive disorder.
In conjunction, the company has additional patent applications for extended-release
oxcarbazepine and extended-release
topiramate pending in other geographic regions.
MucinexA 600mg Extended-Release
tablets (Guaifenesin 600mg Extended-Release
Tablets), an expectorant indicated to relieve chest congestion and make coughs more productive, had sales of approximately $135 million through food, drug and mass merchandisers for the last 12 months.
Dosing forms: 100mg and 150 mg extended-release
Drug-related adverse events, including headache and vaginitis, were reported by 10% of the extended-release
patients and 9% of the other group.
The high-dose extended-release
formulation was well tolerated (Am.
Trokendi XR is now available in 25mg, 50mg, 100mg and 200mg extended-release
capsules, concluded the company.
Participants were randomized to extended-release
acetaminophen at the recommended adult dosage of 1,300 mg t.
The company was awarded the final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Methylphenidate Hydrochloride Extended-Release
Tablets, which is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
SAN DIEGO -- Extended-release
ciprofloxacin appears to be as effective and safe as the conventional twice-daily formulation for the treatment of uncomplicated urinary tract infections in women, Dr.