22 MARKH't' US FDA approvals and committee recommendations J>ruw; rerommended for OTC status The US FDA's advisory committees on gastro- intestinaJ drugs and nonprescription drugs have recommended a switch from prescription to oveNhe-counter (OTC) status for cimetidine for the treatment of heartburn. The OTe version of cimetidine [Tagamet HB I is an alternative therapy to traditional antacids. It suppresses acid production instead of neutralising stomach acidity, reiterated the manufacturer. Smi thKline Beecham. - Media release The FDA advisory panels 00 arthritis and nonprescription drugs have recommended the use of Johnson & Johnson's ibuprofen ('Motrin Suspension'] as an OTC analgesic fo rchildreo with colds and 'flu, sore throat, headache and toothache, according to the Wall Street Journi11 r29 Marl. If apJX"Qved the drug will be the first OTe version of ibuprofen to have a paediatric indication; it will also be the first new OTC ana1gesic to be introduced in 35 years. OraJgnud!mun_ved SmithKline Beecham's oral fannulation of granisetron ['Kytril'J was approved by the US FDA on 16 March for the prevention of antineoplastic theraov-induced nausea and It is the only oraJ 5-lIT 3-receptor antagonist to be indicated for use following initiaJ and repeat cow"ses of high-dose cisplatin therapy, the company points out. - Media n!lease The oral formulation will be launched in early April. repons the Pink Sheet [27 Mar]. The IV formulation of granisetron was approved in the US in December 1993. • Apr 111M15INPMARMA- 01 s&.2703I05I0981.ooD221S01.0ff' Adl. 1m.m.tloNlI u...1ted 1\1815. All rights _

US FDA approvals and committee recommendations

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Page 1: US FDA approvals and committee recommendations

22 MARKH't' ~ US FDA approvals and committee recommendations

J>ruw; rerommended for OTC status The US FDA's advisory committees on gastro

intestinaJ drugs and nonprescription drugs have recommended a switch from prescription to oveNhe-counter (OTC) status for cimetidine for the treatment of heartburn.

The OTe version of cimetidine [Tagamet HB I is an alternative therapy to traditional antacids. It suppresses acid production instead of neutralising stomach acidity, reiterated the manufacturer. SmithKline Beecham. - Media release

The FDA advisory panels 00 arthritis and nonprescription drugs have recommended the use of Johnson & Johnson's ibuprofen ('Motrin Suspension'] as an OTC analgesic forchildreo with colds and 'flu, sore throat, headache and toothache, according to the Wall Street Journi11 r29 Marl. If apJX"Qved the drug will

be the first OTe version of ibuprofen to have a paediatric indication; it will also be the first new OTC ana1gesic to be introduced in 35 years.

OraJgnud!mun_ved SmithKline Beecham's oral fannulation of

granisetron ['Kytril'J was approved by the US FDA on 16 March for the prevention of antineoplastic theraov-induced nausea and vomitin~. It is the only oraJ 5-lIT 3-receptor antagonist to be indicated for use following initiaJ and repeat cow"ses of high-dose cisplatin therapy, the company points out. - Media n!lease

The oral formulation will be launched in early April. repons the Pink Sheet [27 Mar]. The IV formulation of granisetron was approved in the US in December 1993.

• Apr 111M15INPMARMA- 01 s&.2703I05I0981.ooD221S01.0ff' Adl. 1m.m.tloNlI u...1ted 1\1815. All rights _