FDA approves hGH needle-free injection by Teva

The FDA has approved Teva Pharmaceuticals’ hGH needle-free injection, relieving kids requiring medication to enhance their human growth hormone (hGH) levels from fright and pain of shots. Needle-free injectors boost a fine stream of medicated liquid through the skin to the subcutaneous fatty tissue. This liquid is then absorbed by the body.

Teva introduces Nicardipine HCl Injection in US

Teva Pharmaceutical Industries Ltd. has introduced its  Nicardipine Hydrochloride Injection, 2.5 mg/mL, in the United States of America. The injection is the first alternative to EKR Therapeutics’ treatment for high blood pressure, Cardene® I.V. According to IMS sales data, this product had annual sales of approximately $181 million in the United States from July 2007 to June 2008. As part of an agreement that Teva and Exela PharmSci, Inc. (a Reston, Virginia based company developing pharmaceuticals), entered into, Teva is licensed to manufacture and distribute the  Nicardipine HCl Injection.

Teva sues FDA after denial of generic Risperdal exclusivity

Teva Pharmaceuticals has filed a lawsuit in a U.S. district court against the FDA after being denied the 180-day exclusivity for its generic version of the blockbuster antipsychotic Risperdal. Teva said that it was eligible for the 180-day marketing exclusivity, as it was the first to submit an abbreviated new drug application (ANDA) for Janssen Pharmaceutical’s Risperdal (risperidone) tablets with a Paragraph IV certification for the ’952 patent.