Watson subsidiary files application for overactive bladder generic version of Sanctura XR
MORRISTOWN, N.J. A subsidiary of Watson Pharmaceuticals has filed an approval application for a generic version of a drug used to treat overactive bladder.
Watson Labs -Florida announced Wednesday that it had filed an application with the Food and Drug Administration for trospium chloride extended-release capsules in the 60 mg strength. The capsules are a generic version of Allergan’s Sanctura XR.
Because Watson filed its application before the Feb. 1, 2025 expiration of Allergan’s patent, Allergan filed suit against Watson Monday in the U.S. District Court for the District of Delaware, seeking to prevent Watson from marketing the drug. Allergan filed its suit under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson’s generic Sanctura XR for up to two and a half years or until the two companies resolve the matter before the court.
Sanctura XR had sales of about $42 million for the 12 months ending March 31, according to IMS Health data.
Democrats unveil comprehensive healthcare reform bill; industry responds with mixed reviews
WASHINGTON Democrats in the House unveiled a comprehensive healthcare reform bill Tuesday designed to fill the gap that has left nearly 50 million Americans without health coverage.
Dubbed the America’s Affordable Health Care Choice of 2009, the bill will be debated in committee this week, according to the Associated Press, but has already attracted comments from industry organizations, including those representing retailers.
The bill would penalize employers that don’t buy health insurance for employees — exempting small businesses — as well as individuals who refuse to buy it for themselves, but would ban health insurers from denying coverage or charging higher premiums for patients with pre-existing conditions while allowing the government to sell insurance. It would also provide assistance for poor people, financed in part through a tax of 1%, to 5.4% on people making $350,000 or more per year and large cuts to Medicare and Medicaid.
The bill got mixed responses from industry groups. The National Community Pharmacists Association, while saying the bill would require additional review, praised provisions that would begin to reform the way pharmacists are reimbursed for generic drugs dispensed to Medicaid beneficiaries.
“Community pharmacists play a critical role in the healthcare system,” National Community Pharmacists Association EVP and CEO Bruce Roberts said in a statement. “NCPA is committed to ensuring that any health reform legislation does two things: First, it should utilize medication therapy management and other pharmacist-delivered healthcare services to improve patient outcomes and reduce overall costs, such as from improper medication use; second, and more importantly, Congress should assure that there is a viable community pharmacy infrastructure to deliver quality health care to millions of patients across America.”
Other organizations have strongly criticized the measure’s provisions.
In a letter obtained by the Associated Press, 31 business organizations, including the U.S. Chamber of Commerce and the National Retail Federation, strongly criticized the bill.
“Exempting some micro-businesses will not prevent this provision from killing many jobs,” AP quoted the letter as saying. “Congress should allow market forces and employer autonomy to determine what benefits employers provide, rather than deciding by fiat.”
FDA rejects Watson prostate cancer drug
MORRISTOWN, N.J. The Food and Drug Administration has rejected an application from Watson Pharmaceuticals for a new formulation of a prostate cancer drug.
Watson announced Tuesday that the FDA had given it a complete response letter for its approval application for a 24-week formulation of Trelstar (triptorelin pamoate for injectable suspension) in the 22.5-mg strength. Watson had prepared the application with Swiss biotech company Debiopharm Group.
The FDA asked Watson for additional clinical testing data, third-party manufacturing data and data related to chemistry, manufacturing and controls. Watson said it was working to provide the agency with the information requested.