Reddy's OTC Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended-Release
Tablets, USP, are used for temporary relief of symptoms due to hay fever or other upper respiratory allergies that include runny nose; sneezing; itchy, watery eyes; itching of the nose or throat; for temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies; to reduce swelling of nasal passages; for temporary relief of sinus congestion and pressure; and to temporarily restore freer breathing through the nose
'The launch of Aspirin and Extended-Release
Dipyridamole Capsules, an internally developed product, represents a meaningful opportunity,' said Tim Crew, chief executive officer of Lannett.
According to contract research organisation, IQVIA, total US sales of Aspirin and Extended-Release
Dipyridamole Capsules, 25 mg/200 mg, amounted to around USD158m for the 12 months ended April 2019, although actual generic market values are likely to be lower.
According to IQVIA, the US sales for Dalfampridine Extended-Release
Tablets in 10 mg were approximately USD553m for the 12 months ending 30 June 2018.
Panelists voting against approval also said that the Risk Evaluation and Mitigation Strategy (REMS) for extended-release
and long-acting opioids, which was approved by the FDA in July 2012 to minimize abuse and misuse of these drugs, was not stringent enough to ensure the drug would be used safely, citing the need to make prescriber education mandatory and limit distribution of the drug.
Interestingly enough, this extended-release
clonidine formulation also exists in the world under the name, Jenloga, which is approved for the treatment of hypertension in adults.
The opioid drugs on the FDA's list are mostly transdermal or extended-release
oral formulations, and include brandname products fentanyl (Duragesic extended-release
transdermal system), methadone (Dolophine tablets), oxycodone (OxyContin extended-release
tablets), oxymorphone (Opana extended-release
tablets), and several extended-release
oral morphine products.
Adams markets six patent-protected extended-release
guaifenesin products over-the-counter under the Mucinex brand name, including a new line of 1200 mg maximum-strength products.
419, 2004) examined the effect of an extended-release
form of niacin.
Clinical cure of uncomplicated urinary tract infection was achieved at days 4-11 among 95% of 198 women who were treated with 500 mg of extended-release
ciprofloxacin once daily for 3 days, compared with 93% of 220 women treated with 250 mg of immediate-release ciprofloxacin twice daily for 3 days.
M2 PHARMA-June 19, 2019-Lannett Company commences marketing Aspirin and Extended-Release
Global Banking News-August 7, 2018-DURECT announces complete response letter from US FDA for REMOXY ER (oxycodone) Extended-Release