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ProAmatine [R] should not be used in patients with persistent and excessive supine hypertension.
Shire has little incentive to conduct new trials since the entry of generics in 2003 cut into ProAmatine sales, but the disease area does seem to be an attractive one for orphan drug developers.
Last Monday the FDA issued a letter to Shire and several drugmakers that market generic versions of ProAmatine, proposing a withdrawal of the drug from the market.
Shire, the NDA holder for ProAmatine, remains committed to ensuring midodrine remains available for patients who critically need this medicine and who would be left without alternative treatments should it be withdrawn from the market.
Sales of PROAMATINE, for the year ended 31 December 2003 were $49.
Customer de-stocking subsequent to the anticipated launch of generic copies of PROAMATINE in the fourth quarter of 2003, contributed heavily to the decline in revenues between years.
AGRYLIN, PENTASA and PROAMATINE were lower, as predicted, as wholesalers
The Company estimates that Q3 2003 product sales were broadly in line with prescription-based demand for the quarter, however, reported sales of ADDERALL, AGRYLIN, PENTASA and PROAMATINE were lower, as predicted, as wholesalers reduced inventories.
1 IMS Prescription Data - ADHD market 2 IMS Prescription Data - extended release carbamazepine market 3 IMS Prescription Data - AGRYLIN, Hydrea, generic hydroxyurea market 4 IMS Prescription Data - mesalamine / olsalazine market 5 IMS Prescription Data - PROAMATINE and fludrocortisone acetate market 6 IMS Prescription Data - Product specific 7 GSK OVERVIEW OF US GAAP FINANCIAL RESULTS Introduction
The US prescription market1 for PROAMATINE and Florinef prescriptions(1) indicates that PROAMATINE had a 25% share(1) for the month of September 2002 compared to 24% in September 2001.
The US prescription market for PROAMATINE and Florinef prescriptions indicates that PROAMATINE had a 23.