Watson gains two generic approvals
PARSIPPANY, N.J. — Watson Pharmaceuticals announced that its subsidiary, Watson Laboratories, has received Food and Drug Administration approval on its abbreviated new drug application for irbesartan tablets — the generic equivalent to Sanofi’s Avapro — in the 75-mg, 150-mg and 300-mg strengths.
Avapro is indicated for the treatment of hypertension when used alone or in combination with other antihypertensive agents. It is also indicated for the treatment of diabetic nephropathy. Avapro and its generic equivalents had total U.S. sales of approximately $390 million for the 12 months ended Aug. 31, 2012, according to IMS Health data.
Watson Laboratories also received FDA approval on its abbreviated new drug application for trospium chloride extended-release capsules, the generic equivalent to Allergan’s Sanctura XR. For the 12 months ended July 31, 2012, Sanctura XR had total U.S. sales of approximately $67 million, according to IMS Health.
The company plans to begin shipping both products immediately.
NASA, Epiomed Therapeutics partner on development of scopolamine nasal spray
HOUSTON — NASA’s Johnson Space Center and Epiomed Therapeutics have signed an agreement to develop and commercialize a NASA-crafted, fast-acting nasal spray to fight motion sickness.
Under the Space Act Agreement, Epiomed will formulate the drug, called intranasal scopolamine, or INSCOP. Astronauts often experience motion sickness in space. As a result, NASA has conducted extensive research into the causes and treatments for the condition. Scopolamine is effective and can be administered as a tablet or injected. With a precise dosage, the NASA spray formulation has been shown to work faster and more reliably than the oral form.
Scopolamine is currently approved as a prescription-only transdermal patch called Transder Scop, manufactured by Novartis, and is indicated to help prevent nausea and vomiting associated with motion sickness.
"NASA and Epiomed will work closely together on further development of INSCOP to optimize therapeutic efficiency for both acute and chronic treatment of motion sickness which can be used by NASA, the Department of Defense and world travelers on land, in the air and on the seas," stated Lakshmi Putcha, developer of the treatment strategy at Johnson.
A gel formulation of INSCOP was developed and tested under a Space Act Agreement between Johnson and the Naval Aerospace Medical Research Laboratory in Pensacola, Fla. Results from that trial were published in the journal Aviation, Space and Environmental Medicine in April 2010 that suggest INSCOP is a fast-acting and reliable way to prevent and treat motion sickness.
The U.S. Navy is working on an agreement with Epiomed to test the nasal spray. NASA and Epiomed will collaborate on clinical trials related to the Federal Drug Administration requirements. NASA is transferring sponsorship of future clinical trials and FDA approvals to Epiomed, which will supply the product for use by NASA and others.
FDA approves new use for Genentech arthritis drug
SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a new use for a drug made by Roche division Genentech.
The drug maker said Friday that the FDA had approved Actemra (tocilizumab) for adults with moderately to severely active rheumatoid arthritis who have not responded adequately to one or more disease-modifying antirheumatic drugs. The drug was already approved for systemic juvenile idiopathic arthritis.
"People with moderately to severely active RA can suffer irreversible joint damage that may be prevented by earlier treatment with a biologic medicine such as Actemra," Genentech chief medical officer and head of global product development Hal Barron said. "We’re pleased that these patients will now have Actemra as an additional option."