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Bayer AG

Latest From Bayer AG

Primatene Mist NDA Expected By July After FDA OKs OTC Asthma Inhaler Trial

Amphastar plans this month to begin what it expects to be its final study to support an NDA to relaunch Primatene Mist. If the results support accurate self-selection and usage of the product by consumers, Amphastar should be ready to re-submit the NDA during the current quarter.
Respiratory Consumer

PEG 3350 Laxatives: FDA Allows Firms 6 Months To Make Their Case For Rx Products

FDA agrees with Breckenridge Pharmaceutical, Nexgen Pharma, Lannett Co. and Paddock Labs that ending availability of their Rx PEG 3350 products on May 2 would cause a shortage of the drug available to consumers. Saying "it likely would be difficult for manufacturers of OTC PEG 3350 products to compensate for the removal" of the Rx drugs by that date, FDA extends the deadline to Nov. 2.

Prescription To Otc Switch Consumer

Rx PEG Firms Give FDA Deadline Before Asking Court To Delay ANDA Withdrawals

Breckenridge Pharmaceuticals and Nexgen Pharma file a citizen petition asking FDA to delay effective date for the agency's order that withdrawing approval of all abbreviated new drug applications for Rx generic polyethylene glycol 3350 laxatives. Absent quick reply, the companies may seek emergency court action.


Consumer Gastrointestinal

Giant LEAPS For Mankind: Bayer's Malik On Breaking The Mold In R&D

As new scientific breakthroughs are shaking the foundations of pharma and biotech R&D, In Vivo sat down with Bayer's Kemal Malik to hear how the German big pharma is responding to the challenges with its ground-breaking LEAPS program.

Financing Regenerative Medicine
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