FDA approves Aurobindo Pharma’s generic Lotensin
WASHINGTON Generic drug manufacturer Aurobindo Pharma has received final approval from the Food and Drug Administration to manufacture a generic version of Novartis Pharmaceuticals’ drug Lotensin, the company announced Tuesday.
Benazepril hydrochloride, the drug’s chemical name, is used to treat hypertension. The FDA granted Aurobindo approval to manufacture tablets in 10 mg, 20 mg and 40 mg doses.
Based in Hyderabad, India, Aurobindo manufacturers generic medicines and active pharmaceutical ingredients. Its products include antibiotics and anti-retroviral drugs, CVS, CNS, gastroenterological drugs and anti-allergy drugs.
Takeda could see Alogliptin approval in near future
OSAKA, Japan Japanese pharmaceutical manufacturer Takeda’s new diabetes drug could get approval soon, according to Bloomberg.
According to the financial news agency, reports by analysts showed that the drug, alogliptin, had promise after the American Diabetes Association released parts of nine studies of the medication that were submitted for marketing approval in the U.S. in January, last week. They show the drug lowered blood sugar levels as much as Merck’s Januvia without serious side effects.
Alogliptin, also known as SYR-322, will compete with Merck’s Januvia and Novartis’ Galvus, which is also up for approval at the Food and Drug Administration. All three drugs are in a new class of diabetes treatments known as DPP4 inhibitors that signal the pancreas to produce more insulin and the liver to make less glucose, or blood sugar.
Assuming approval by the Food and Drug Administration, Alogliptin will succeed Actos, which generates about 29 percent of Takeda’s current revenue. Actos will lose patient approval in 2011.
Accutane ingredient linked to increased risk of depression
NEW YORK A study published in the Journal of Clinical Psychiatry has shown a link between use of the acne drug isotretinoin and increased risks of depression.
The drug was shown to more than double the risk of depression in a study of more than 30,000 people in Quebec who had received at least one prescription for it between 1984 and 2003.
Roche Pharmaceuticals’ drug Accutane has isotretinoin as its main active ingredient. The FDA originally granted approval to the drug in 1982.