Medication Monitor



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Generic Name (Trade Name—Company)
Notes
  • August 5, 2016

    FDA has approved the first generic version of Tamiflu—oseltamivir phosphate—a widely used medication to treat influenza A and B in patients aged 2 weeks and older who have had influenza symptoms for no more than 48 hours, and to prevent influenza in patients aged 1 year and older. Tamiflu was approved in 1999.

    The most common adverse effects reported by participants using oseltamivir phosphate in clinical trials included nausea and vomiting.

    Patients must use oseltamivir phosphate as directed by their health care provider. Oseltamivir phosphate does not take the place of receiving an influenza vaccination. Advise patients to talk to their health care provider about when to receive an annual influenza vaccination.

    Oseltamivir phosphate does not treat or prevent illness caused by infections other than the influenza virus, and oseltamivir phosphate does not prevent bacterial infections that may happen with influenza. FDA does not know if oseltamivir phosphate is effective in people who start treatment after 2 days of developing symptoms or have weakened immune systems.

    Patients and health care providers may find more information about oseltamivir phosphate in the drug label.

  • July 7, 2002

    Uses:

    Management of seizures and a variety of pain conditions

    Lupin Pharmaceuticals announced that it has received FDA approval to market its generic version of Pfizer’s Lyrica capsules. The pregabalin capsules are AB rated to Pfizer's product and will be available in 25-, 50-, 75-, 100-, 150-, 200-, 225-, and 300-mg strengths.

    Pregabalin is indicated for neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, adjunctive therapy for adult patients with partial onset seizures, neuropathic pain associated with spinal cord injury, and fibromyalgia.

  • December 23, 2014

    Long-acting release (LAR) pasireotide, a next-generation somatostatin analog (SSA), has received FDA approval for patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.

    Acromegaly is a rare and life-threatening hormonal disorder caused by elevated growth hormone and insulin-like growth factor-1 levels.

    Approval was based on two multicenter Phase III studies involving medically naive patients who had prior surgery or for whom surgery was not an option and patients with acromegaly inadequately controlled on first generation SSAs. In both studies, higher rates of full biochemical control were achieved with LAR pasireotide compared with a first-generation SSA.

    The drug is administered intramuscularly once monthly.

  • December 14, 2018

    Mayne Pharma announced FDA approval of SUBA-itraconazole 65 mg capsules, a new formulation of itraconazole that targets certain systemic fungal infections in adult patients.

    The agent is indicated for the treatment of blastomycosis (pulmonary and extrapulmonary), histoplasmosis (including chronic cavitary pulmonary disease and disseminated, nonmeningeal histoplasmosis) and aspergillosis (pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy).

    These serious infections most commonly occur in vulnerable or immunocompromised patients, for example, those with a history of cancer, transplants (solid organ or bone marrow), HIV/AIDS, or chronic rheumatic disorders, and are often associated with high mortality rates or long-term health issues.

    The product will launch in January 2019, according to the manufacturer.

  • January 27, 2015

    FDA has approved the first generic version of Nexium—esomeprazole magnesium delayed-release capsules—to treat gastroesophageal reflux disease (GERD) in adults and children aged 1 year and older. Esomeprazole is a proton pump inhibitor (PPI) that reduces the amount of acid in the stomach.

    Ivax Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals, has gained approval to market esomeprazole in 20-mg and 40-mg capsules.

    Esomeprazole capsules are also approved to reduce the risk of gastric ulcers associated with use of nonsteroidal anti-inflammatory drugs (NSAIDs), treat the stomach infection Helicobacter pylori along with certain antibiotics, and to treat conditions where the stomach makes too much acid, including Zollinger-Ellison syndrome.

    The most serious risks with generic esomeprazole capsules are stomach problems, including severe diarrhea, and a warning that people who take multiple daily doses of PPIs for a long period of time may have an increased risk of bone fractures. 

    The most common adverse effects reported in clinical trials include headache, diarrhea, nausea, flatulence, abdominal pain, sleepiness, constipation, and dry mouth.

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