Amneal’s generic Renvela comes to market
Amneal Pharmaceuticals has launched sevelamer carbonate tablets, 800 mg, in 270-count bottles. This generic from the Bridgewater, N.J.-based company is an AB-rated therapeutic equivalent to Renvela.
Amneal also launched five other products in addition to sevelamer carbonate:
- Progesterone capsules, AB-rated equivalent to Prometrium in 100-mg and 200-mg strengths;
- Bumetanide tablets, USP, AB-rated to Bumex, in 0.5 mg, one-mg and two-mg strengths;
- Ezetimibe and Simvastatin tablets, an AB-rated generic for Vytorin in four strengths;
- Clonidine HCl Extended-Release Tablets, AB1-rated to Kapvay in 0.1 mg strength; and
- Triamcinolone Acetonide Injectable Suspension, USP in 40-mg/mL strength.
“Our approval and launch of sevelamer carbonate tablets is yet another example of Amneal’s commitment to successfully provide complex pharmaceutical products to the US market,” Jim Luce, Amneal executive vice president of sales and marketing, said. “Our pipeline continues to grow with more than 132 ANDAs filed and another 140 in development.”
PharmaJet, Invectys enter Phase 2 cancer vaccine trial
Needle-free injection technology company PharmaJet, based in Golden, Colo., will be working with French biopharma company Invectys to test Invectys’ therapeutic cancer vaccine. The Phase 2 trial is for INVAC-1, which uses PharmaJet’s needle-free injection system and is an immunotherapeutic DNA vaccine meant to treat cancer, the companies said.
“We believe the PharmaJet Needle-free device offers many advantages to patients and providers including less pain and stress, elimination of needles and provides a more precise and consistent method for vaccine delivery,” Invectys CEO Pierre Langlade Demoyen said.
PharmaJet said that it has previously tested its Tropis needle-free injection system in huyman and animal clinical trials without evidence of safety concerns.
“We are pleased that the PharmaJet Tropis Intradermal device has been chosen as the method of administration for this important cancer immunotherapy vaccine development.” PharmaJet CEO and chairman Ron Lowy said. “The Needle-free device is safe, fast and easy to administer, and has already been used successfully in numerous clinical studies for nucleic acid (DNA or RNA) vaccine delivery.”
Dr. Reddy’s reaches settlement regarding Consumer Product Safety Act compliance
It has been announced by the United States subsidiary of Dr. Reddy’s Laboratories, that the company has reached a settlement with the U.S. Government in a case involving packaging for five blister-packed prescription products.
In a joint filing, both parties have agreed to a settlement of the action without any adjudication or issue of fact or law. The matter has been settled for $5 million dollars, and the product in question has not been distributed in the packaging at issue since June 2012, the company said.
The company also said that it is not aware of any reports that a child gained access to the products as a result of the packaging, or that the products have caused harm to a child as a result of the packaging. Dr. Reddy’s said that it is committed to complying with all applicable requirements of the Consumer Product Safety Act, which includes applicable packaging and reporting requirements.