FDA approves expanded label for Teva’s Azilect
JERUSALEM — Teva on Monday announced that the Food and Drug Administration approved an expanded label for Azilect (rasagiline tablets) from monotherapy and adjunct to levodopa to now include dopamine agonists. The approval reflects that Azilect can be used alone or with other Parkinson’s disease medications.
"The FDA approval of the expanded label for Azilect will be a welcome addition in the treatment of PD," said Michael Hayden, M.D., Ph.D., president of global research and development and chief scientific officer at Teva Pharmaceutical Industries. "Teva continues its commitment to those living with PD and to research in areas of neurodegenerative diseases to develop solutions for patients with unmet needs."
The FDA’s approval was supported by data from the ANDANTE study (add on to dopamine agonists in the treatment of Parkinson’s disease), which demonstrated that Azilect imoproved total Unified Parkinson’s Disease Rating Scale scores.
Mylan launches generic Paraplatin injection
PITTSBURGH — Mylan on Monday announced the launch of carboplatin injection, 50-mg/5-ml, in multi-dose vials. The drug is the generic version of Paraplatin injection from Bristol-Myers Squibb.
The company also received final approval for the carboplatin injection 150-mg/15-ml, 450-mg/45-ml and 600-mg/60-ml multi-dose vials, with plans to launch those strengths at a later date.
Carboplatin injection is used for the initial treatment of advanced ovarian carinoma in combination with other approved drugs. Carboplatin had sales in the United States of $30.4 million for the 12 months ended March 31, according to IMS Health.
New Softlips Cubes hits retail shelves
ORCHARD PARK, N.Y. — Mentholatum Co.’s Softlips brand is now debuting at retail its new Softlips Cube.
The new dome-shaped balm is a 5-in-1 formula that promises to hydrate, replenish, smooth, protect with SPF 15 and add a subtle sheen.
The suggested retail price is $3.49 and comes in new flavors: pomegranate blueberry, fresh mint and vanilla bean.