Perrigo announced that it has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for over-the-counter (OTC) Cetirizine Hydrochloride Tablets, 5 and 10 mg.The product will be marketed under store brand labels and is comparable to McNeil Consumer Healthcare's Cetirizine Hydrochloride Tablets, 5 and 10 mg, which will be marketed as Zyrtec(R) Tablets, indicated for allergy and hives relief. According to Wolters Kluwer data, brand sales for the original prescription strength version of the product for the 12 months ending October 2007 were approximately $1.4 billion.
Mylan Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets (OTC), 5 mg and 10 mg.Cetirizine HCl Tablets are the generic version of Pfizer's Zyrtec(R) Tablets, which had U.S. sales of approximately $1.4 billion for the 12 months ending Sept. 30, 2007.This product will be shipped immediately.
Ranbaxy has received final approval from the USFDA to manufacture and market cetirizine hydrochloride tablets, 5 mg and 10 mg. The office of generic drugs, US Food and Drug Administration, has determined the Ohm formulation to be bioequivalent and have the same therapeutic effect as that of the reference listed drug zyrtec allergy tablets, 5mg and l0mg and zyrtec hives relief tablets, 5mg and 10mg by Pfizer Pharmaceuticals Inc. Total annual market sales for cetirizine hydrochloride tablets as a prescription only product were $1.3 billion (IMS - MAT: September 2007).Cetirizine hydrochloride is indicated for the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies."We are pleased to receive this final approval for cetirizine hydrochloride tablets (OTC) 5mg and 10mg that have proven its clinical value and utility in both adults and children. We are pleased to offer this preferred formulation that will meet the needs of all patients who need this medication in response to allergic reactions. This OTC product formulation further expands our portfolio of affordable generic alternatives and will be launched immediately to all classes of trade," said Jim Meehan, vice president of sales and distribution for Ohm Laboratories Inc, a wholly owned subsidiary of RLL.Ohm, based in North Brunswick, New Jersey, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company. Ohm is engaged in the sale and distribution of generic and branded private label, OTC products in the US healthcare system.
Mylan Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets (OTC), 5 mg and 10 mg.Cetirizine HCl Tablets are the generic version of Pfizer's Zyrtec(R) Tablets, which had U.S. sales of approximately $1.4 billion for the 12 months ending Sept. 30, 2007.This product will be shipped immediately.
Ranbaxy has received final approval from the USFDA to manufacture and market cetirizine hydrochloride tablets, 5 mg and 10 mg. The office of generic drugs, US Food and Drug Administration, has determined the Ohm formulation to be bioequivalent and have the same therapeutic effect as that of the reference listed drug zyrtec allergy tablets, 5mg and l0mg and zyrtec hives relief tablets, 5mg and 10mg by Pfizer Pharmaceuticals Inc. Total annual market sales for cetirizine hydrochloride tablets as a prescription only product were $1.3 billion (IMS - MAT: September 2007).Cetirizine hydrochloride is indicated for the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies."We are pleased to receive this final approval for cetirizine hydrochloride tablets (OTC) 5mg and 10mg that have proven its clinical value and utility in both adults and children. We are pleased to offer this preferred formulation that will meet the needs of all patients who need this medication in response to allergic reactions. This OTC product formulation further expands our portfolio of affordable generic alternatives and will be launched immediately to all classes of trade," said Jim Meehan, vice president of sales and distribution for Ohm Laboratories Inc, a wholly owned subsidiary of RLL.Ohm, based in North Brunswick, New Jersey, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company. Ohm is engaged in the sale and distribution of generic and branded private label, OTC products in the US healthcare system.
1 comment:
sup doc? You really into the, pill trials eh? Better you than me, I would just end up pocketing the good stuff and end up getting arrested in a pat down. Keep it real ese, I know you are bright and intelligent and making all drugs safe for us in the world.
The bird is the word!
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