The FDA has approved AstraZeneca’s Symbicort (budesonide/formoterol) for the maintenance treatment of asthma in patients age 12 and older.
Biogen Idec and Elan yesterday announced the commercial availability of Tysabri (natalizumab) for the treatment of relapsing forms of multiple sclerosis (MS) in the US.
Endo Pharmaceuticals has announced the commercial availability of Opana ER and Opana tablets indicated for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. Endo has begun shipments to its customers and is instituting a wholesale and retail stocking program to ensure these products are distributed to retail pharmacies across the US over the next several weeks.
Oscient Pharmaceuticals has agreed to acquire US rights to the cardiovascular product Antara 130 mg (fenofibrate) capsules from Reliant Pharmaceuticals. Antara is part of the $1 billion fenofibrate market, and upon closing the award, will be commercialized by Oscient's national sales force, which currently is marketing Factive (gemifloxacin mesylate) tablets and Testim 1% testosterone gel. Under the terms of the agreement, Oscient will make a payment of $78 million to Reliant for US rights to Antara, plus a purchase of approximately $4 million in existing inventory.
Shire announced that the FDA has granted marketing approval for Elaprase, a human enzyme replacement therapy for the treatment of Hunter syndrome, also known as Mucopolysaccharidosis II (MPS II). Hunter syndrome is a rare, life-threatening genetic condition that results from the absence or insufficient levels of the lysosomal enzyme iduronate-2-sulfatase. Without this enzyme, cellular waste products accumulate in tissues and organs, which then begin to malfunction.
Advancis Pharmaceutical, a company focused on developing and commercializing novel anti-infective products, announced the commercial launch of Keflex 750 mg capsules. The new strength of Keflex allows health care professionals the flexibility to deliver higher doses of Keflex with fewer capsules per day. Keflex 750 mg capsules have been manufactured, packaged, and are currently being distributed to pharmacies nationwide in bottles of 50. Keflex is indicated for treatment of respiratory tract infections, otitis media, skin and skin structure infections, bone infections, and genitourinary tract infections.
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