USFDA approves Granules drug for migraine
By IANS |
Published on
Wed, Feb 24 2021 20:36 IST |
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Migraine Attack (Photo: Pixabay). Image Source: IANS News
Hyderabad, Feb 24 : Granules India Ltd on Wednesday announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for acetaminophen, aspirin, and caffeine tablets, indicated for the treatment of migraine.
It is bioequivalent to the Reference Listed Drug (RLD) product, Excedrin Migraine tablets, 250 mg/250 mg/65 mg, of GlaxoSmithKline Consumer Healthcare.
The product would be manufactured at Granules India s Hyderabad facility and is expected to be launched shortly. We are pleased to announce approval of Acetaminophen, Aspirin and Caffeine tablets, emphasising our focus on building a sustainable OTC product portfolio in the US market. We received approval for this triple combination product within 14 months from filing. With this, we have receiv
Excedrin recalled over reports of holes in bottles, poisoning risk Share Updated: 1:04 PM EST Dec 29, 2020 National Desk Staff Share Updated: 1:04 PM EST Dec 29, 2020 National Desk Staff A New Jersey manufacturer has recalled five brands of Excedrin caplets due to reports of holes in bottles that could pose a risk of poisoning. According to the Consumer Product Safety Commission, approximately 433,600 bottles of Excedrin Migraine caplets, Excedrin Migraine geltabs, Excedrin Extra Strength caplets, Excedrin PM Headache caplets and Excedrin Tension Headache caplets are affected by the recall. The recall involves 50, 80, 100, 125, 200, 250 and 300-count bottles of those brands produced at GSK Consumer Healthcare in Warren, New Jersey.Pharmacies, department stores and grocery stores nationwide and online sold the bottles from March 2018 through September 2020 for between $7 and $18. Some of the bottles containing the over-the-counte
These products contain Aspirin and Acetaminophen, which are required to be in child-resistant packaging.
If you have one of these products and there is a hole in the bottle, keep it out of the reach of children. Then contact Glaxo Smith Kline for information on how to receive a pre-paid shipping label for the return to receive a full refund.
The recall impacts more than 430,000 bottles.
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On their website, Excedrin is asking consumers to check their bottles for holes, which are likely to be around the base of the bottle. While the likelihood there are bottles on the market with holes is low, we are asking anyone who has purchased large-sized Excedrin (50 count and above) to check their Excedrin products and if there is a visible issue, contact GSK Consumer Relations at 1-800-468-7746 for a full refund, said the company. If your Excedrin bottle is not damaged, the product is safe to use as directed on the label.
The bottles in question were sold at pharmacies, department stores, grocery stores and online from March 2018 through September 2020 for between $7 and $18. There was no explanation given on what caused the holes in some of the bottles.
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