Generic Estrostep poised to break into U.S. market
ROCKAWAY, N.J. Under a supply agreement between Warner Chilcott Co. and Watson Pharmaceuticals, generic drug maker Watson will supply Tilia Fe, the generic of Warner Chilcott’s popular oral contraceptive Estrostep FE.
Under the terms of the agreement, Warner Chilcott will supply Tilia (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets) to Watson Pharma, which will be responsible for the marketing, sales and distribution of the generic product in the United States. Warner Chilcott will receive a share of the profits.
Meanwhile, Barr Laboratories received approval from the Food and Drug Administration for its abbreviated new drug application to manufacture and market its own generic version of Estrostep.
Once Barr launches its product, which will be named TriLegest Fe, its generic oral contraceptive portfolio will contain 25 products, the company said.
In April 2004, Warner Chilcott and Barr entered an agreement to settle patent litigation under which Barr was granted a nonexclusive license to launch a generic version of Estrostep in October 2007, six months prior to the last patent expiration on the drug.
FDA approves supplemental NDA for Januvia
WASHINGTON The FDA approved a supplemental new drug application for Merck’s Type 2 diabetes drug Januvia, citing new uses and additional warnings.
The pharmaceutical company, which produces several heart-related medications, had received feedback from patients taking Januvia (sitagliptin) experiencing health problems including anaphylaxis, angioedema and undesirable skin conditions. There had been reports that patients experienced the potentially fatal skin condition known as Stevens-Johnson Syndrome.
Januvia’s revised labeling will now indicate that patients with a history of hypertension should not use the drug. The company said, however, it could not establish a causal relationship to the drug or reliably estimate the frequency of the side effects.
The updated labeling additionally states that Januvia can be used as an initial therapy or add-on therapy with other medications, including metformin and sulfonylurea.
House Dems push through revised SCHIP, but GOP claims partisanship
WASHINGTON The House of Representatives approved a new version of legislation to expand the State Children’s Health Insurance Program yesterday, but the vote failed to get any more Republicans to override another promised veto from President Bush.
Democratic leaders decided the new revision would state the exclusion of illegal immigrants from the program, which would motivate state governments to drop families earning more than 300 percent of the poverty line, which will ultimately force adults off of the program.
Under both versions, the combined average monthly enrollment in SCHIP and Medicaid would be about 34.1 million people, according to the Congressional Budget Office. But there is a shift toward serving poorer children, a key Republican demand. In the new bill, Medicaid enrollment alone would be about 400,000 individuals higher than under the vetoed bill, while SCHIP enrollment would be about that much lower, according to CBO documents.
Almost half of the 3.9 million uninsured children projected to gain coverage under the revised bill, of whom about 80 percent live below the poverty level, would be covered under Medicaid, said Genevieve Kenney, an Urban Institute health economist.
According to The Washington Post, the 265 to 142 tally included 43 Republicans, two fewer than the version that passed Sept. 25.
Republicans called for a postponement of the vote due to the absence of nine members House touring the wildfire disaster in California, but Speaker Nancy Pelosi, D-Calif., insisted she had no choice but to move forward and give the Senate a chance to send the measure to Bush next week. “If Republicans believe in SCHIP as they say they do . . . then they won’t be looking for an excuse to vote against the bill,” Pelosi said.