FDA agrees to review Victory Pharma’s MGX006 NDA
SAN DIEGO Victory Pharma announced that the U.S. Food and Drug Administration has agreed to review its New Drug Application MGX006.
MGX006 is a proven antiemetic agent typically used to treat nausea and vomitting.
“Acceptance of the MGX006 is a significant milestone, it demonstrates Victory’s ability to grow its commercial portfolio via internal product development in addition to in-licensing products,” said Matt Heck, CEO of Victory. “Pending FDA approval, we are planning for a first half of 2010 product launch, allowing Victory to further leverage its 150 person field sales organization. Given many patients suffering from pain also suffer from emesis, there is a good fit between MGX006 and Victory’s growing, pain management franchise.”
Approximately 25 million prescriptions are written annually in the U.S. for antiemetic therapeutics, many of which are taken orally and can cause problems amongst patients. If approved, MGX006 will offer those suffering with emesis with an alternative medication option.
Caraco to acquire rights to several drugs from Forest Labs
NEW YORK Generic drug maker Caraco Pharmaceutical Labs will acquire rights to several drugs from Forest Labs under an asset purchase agreement between the two companies.
Caraco announced the agreement Friday as part of a settlement that it and parent company Sun Pharmaceutical Industries had entered with Forest Labs and Danish drug maker H. Lundbeck concerning Caraco’s regulatory approval application for the anxiety and depression drug Lexapro (escitalopram oxalate). Lundbeck had licensed Lexapro to Forest on an exclusive basis in the United States.
Under the agreement, Caraco will take over commercialization and sale of several products from Forest’s Inwood business, paying Forest an advance against royalties. Meanwhile, Forest will reimburse Caraco for a portion of its legal fees and provide licenses to Caraco for certain Lexapro patents as soon as a third-party generic version with Food and Drug Administration approval hits the market.
Watson Pharmaceuticals gets the OK from FDA for new nicotine polacriliex gum
MORRISTOWN, N.J. Watson Pharmaceuticals, a leader in generic and specialty branded pharmaceuticals, announced its subsidiary, Watson Labs, has been granted approval from the Food and Drug Administration to market its nicotine polacrilex gum.
Nicotine polacrilex gum is the generic equivalent of GlaxoSmithKline Consumer Healthcare’s Nicorette Fruit Chill and Cinnamon Surge Coated gums, all of which are available over-the-counter and used to help people stop smoking.
Watson’s nicotine gum will be available as soon as possible in coated fruit and cinnamon flavors.