22 MARKET NEWS Recent US FDA approvals A combination formulation of enaIapriUdiltiazem ['Teczem'; Hoechst Marion Roussel] has been approved by the US FDA for the treatment of hypertension.! The enalaprilldiltiazem combination is indicated for use after monotherapy has failed, rather than as first-line therapy. 'Teczem' is the first product to combine an ACE inhibitor and a non-dihydropyridine calcium antagonist. Pentosan polysulfate ['Elmiron'; Ivax] has been approved in the US for use in interstitial cystitis, reports Scrip.2 Previously, the drug had been available in the US on a compassionate-use basis. Pentosan polysulfate will be priced at $US125 for 100 x 100 capsules. The drug is already available in Australia and Canada. The combined Haemophilus inj1uenzae type blhepatitis B vaccine 'Comvax' [Merck & Co] has been approved in the US for use in infants aged between 6 weeks and 15 months, reports the Pink Sheet. 3 Clinical trials involving 1216 healthy infants have demonstrated 'Comvax' to be immunogenic and generally well tolerated. The vaccination schedule comprises 1M injections of 'Comvax' at 2, 4 and 12-15 months of age. 'Comvax' is expected to become available in January 1997. 1 PR Newswire, http://www.ncwspage.com2.Ivax·EImiron3plXOVooinUS.Saip 2170: 23, 8 Oct 19963. M=k Comvax haemophilus BIhepaIitis B vaccine combo. FDC Reports - Pink Sheet - PresaipdOn Pbannaceuticals and Biotechnology 58: T&G3,7 Oct 1996 8004SS191 Inpharma 8 19 Oct 1996 No. 1059 0156-2703l9611059'()OO22l$01.00 C Adls International Limned 1996. All rights reserved

Recent US FDA approvals

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22 MARKET NEWS Recent US FDA approvals

A combination formulation of enaIapriUdiltiazem ['Teczem'; Hoechst Marion Roussel] has been approved by the US FDA for the treatment of hypertension.! The enalaprilldiltiazem combination is indicated for use after monotherapy has failed, rather than as first-line therapy.

'Teczem' is the first product to combine an ACE inhibitor and a non-dihydropyridine calcium antagonist.

Pentosan polysulfate ['Elmiron'; Ivax] has been approved in the US for use in interstitial cystitis, reports Scrip.2 Previously, the drug had been available in the US on a compassionate-use basis.

Pentosan polysulfate will be priced at $US125 for 100 x 100 capsules. The drug is already available in Australia and Canada.

The combined Haemophilus inj1uenzae type blhepatitis B vaccine 'Comvax' [Merck & Co] has been approved in the US for use in infants aged between 6 weeks and 15 months, reports the Pink Sheet.3

Clinical trials involving 1216 healthy infants have demonstrated 'Comvax' to be immunogenic and generally well tolerated. The vaccination schedule comprises 1M injections of 'Comvax' at 2, 4 and 12-15 months of age.

'Comvax' is expected to become available in January 1997. 1 PR Newswire, http://www.ncwspage.com2.Ivax·EImiron3plXOVooinUS.Saip 2170: 23, 8 Oct 19963. M=k Comvax haemophilus BIhepaIitis B vaccine combo. FDC Reports - Pink Sheet - PresaipdOn Pbannaceuticals and Biotechnology 58: T&G3,7 Oct 1996 8004SS191