Amneal ships opioid-dependence drug
BRIDGEWATER, N.J. — Amneal Pharmaceuticals has started shipping a drug used to treat opioid dependence, the company said Tuesday.
The generic drug maker announced the shipment of buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablets in the 2-mg/0.5-mg and 8-mg/2-mg strengths. The Food and Drug Administration approved the drug in February.
The drug includes a risk evaluation and mitigation strategy, or REMS, a program required by the FDA to ensure that its benefits outweigh its risks.
The drug is a generic version of Reckitt Benckiser Healthcare’s Suboxone, which had sales of $1.5 billion in 2012, according to IMS Health.
Dr. Reddy’s launches generic cancer drug
HYDERABAD, India — Generic drug maker Dr. Reddy’s Labs has launched a drug used to treat certain cancers, the company said Tuesday.
Dr. Reddy’s announced the launch of injectable zoledronic acid in the 4-mg-per-5-mL strength. The launch followed the Food and Drug Administration’s approval of the drug.
The drug is a generic version of Novartis’ Zometa. The drug is used to treat cancers that have spread to the bones and multiple myeloma.
CORRECTION: An earlier version of this story misstated the strength of the drug. The story has been corrected.
Actavis seeks approval for testosterone-replacement gel
PARSIPPANY, N.J. — Drug maker Actavis is challenging the patent for a drug used to treat testosterone deficiency or absence in men, the company said.
Actavis, formerly known as Watson Pharmaceuticals, said it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Endo Pharmaceuticals’ Fortesta (testosterone) gel in the 10 mg-per-0.5 g strength.
Endo and partnering company Strakan International filed suit against Actavis in the U.S. district Court for the Eastern District of Texas Marshall Division seeking to prevent Actavis from launching its product. The lawsuit puts an automatic stay of FDA approval on the drug for up to 30 months or until the companies settle the suit. Actavis said it was likely the first company to file an approval application with the FDA for the drug, which would entitle it to 180 days’ of market exclusivity in which to compete directly with the branded version following FDA approval.
Fortesta had sales of about $50 million in 2012, according to IMS Health.