FDA issues approvable letter to Noven for Stavzor
MIAMI Noven Pharmaceuticals has received an approval letter from the Food and Drug Administration for its drug Stavzor, which is used for the treatment of manic episodes associated with bipolar disorder, adjunctive therapy in multiple seizure types (including epilepsy), and prophylaxis of migraines.
The FDA has requested some non-clinical information as a condition of final approval. Because the application references the drug Depakote, final approval is also subject to the expiration of any applicable exclusivity periods benefiting the drug.
Noven expects the final approval to be at the latest, by the end of July 2008. The drug will be available in 125 mg, 250 mg and 500 mg strengths.
Mylan, GSK enter agreement over generic Paxil
PITTSBURGH, Pa. Mylan Inc. and its subsidiary Mylan Pharmaceuticals have entered into an agreement with GlaxoSmithKline in relation to Paroxetine Hydrochloride Extended-release tablets, the generic version of Paxil CR.
Under the agreement, Mylan is given the right to market all three strengths of the drug: 12.5 mg, 25 mg and 37.5 mg, beginning no later than Oct. 1, 2008. Mylan received eligibility for a 180-day marketing exclusivity for the 12.5 mg and 25 mg on June 29th.
The generic had U.S. sales of about $342 million for the 12 months ending June 30, 2007 for all three strengths.
Rite Aid announces that wildfire victims can pick up their prescriptions at any location
CAMP HILL, Pa. Rite Aid announced Monday that any of its customers impacted by the Southern California wildfires can continue to fill or pick up their prescriptions at any open Rite Aid, even if their neighborhood store has been evacuated.
This includes prescriptions that have been filled at a closed store but not yet picked up, the company stated.
There are currently 17 active fires in Southern California, according to the state government. There is currently a mandatory evacuation order in place for Rancho Bernardo, Scripps Ranch and Del Mar/Solana Beach.
President George Bush on Tuesday declared that a federal state of emergency exists in the California and ordered federal aid to supplement state and local response efforts in the area struck by wildfires beginning on Oct. 21, and continuing.
The President’s action authorizes the Department of Homeland Security, Federal Emergency Management Agency to coordinate all disaster relief efforts in the counties of Los Angeles, Orange, Riverside, San Bernardino, San Diego, Santa Barbara and Ventura.
“I thank President Bush for granting my request to declare a federal state of emergency in California,” stated Gov. Arnold Schwarzenegger Tuesday morning. The people of California need all the help they can get at this tragic time and this action will allow our citizens to get the assistance they need.”