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Sandoz 8 articles

Blister packs of drugs recalled because they are not child resistant

Novartis and Sandoz are recalling several blister packaged prescription medications because they fail to meet child-resistant closure requirements as required by the Poison Prevention Package Act. The companies have received one report of a child consuming the antipsychotic haloperidol from a blister pack. The recall affects about 470,000 units and includes drugs packaged with 3 to 10 tablets per blister card. The blister packs were designed for use in hospitals but some were sent to retail pharmacies and were likely dispensed for in-home use. Novartis products affected by the recall include the anti-nausea drug Zofran ODT (ondansetron) 4mg and 8 ... Read More

Change.org petition urges FDA to add severe withdrawal warnings to motion sickness patch

The wife of a man who suffers recurrent severe withdrawal symptoms from a transdermal patch used to treat motion sickness has started a petition on Change.org to urge the Food and Drug Administration (FDA) to add new warnings to the safety label regarding long-term use, and to raise awareness of the need for further medical research into severe adverse reactions with longer-than-recommended use of the drug. The petition targets the brand name skin patch TransdermScop as well as any other form of scopolamine. The medication is approved by the FDA to treat motion sickness and postoperative nausea and vomiting. It ... Read More

FDA warning letter: Pfizer’s generic of top-selling MS drug Copaxone likely to be delayed

Food and Drug Administration (FDA) clearance of Pfizer Inc.’s generic version of the top-selling multiple sclerosis (MS) drug Copaxone is expected the first quarter of 2017, but an agency warning letter disclosed last week regarding a May 2016 inspection could delay that approval. Copaxone is manufactured by Teva Pharmaceutical Industries Ltd., and is one of the world’s best-selling drugs, generating sales of $3.5 billion last year in the U.S. alone. Pfizer’s generic, called Glatopa, is manufactured partnership with Sandoz Inc. and Momenta Pharmaceuticals Inc. Glatopa has been available in a 20-milligram version since 2015, but the 40-milligram version makes up about 84 percent ... Read More

Withdrawal from motion sickness patch linked to severe, lingering effects

It took nine days for Dave Maeder to go through withdrawal from the medication patch he was prescribed to treat nausea caused by a brain injury. Nine days of tortuous symptoms like severe nausea and vomiting, insomnia and sleepiness, restlessness and paranoia. It was like he was withdrawing from heroin. But the medicine patch Dave was on – scopolamine – is not a controlled substance. It does not give users a euphoric feeling. It’s not sought after as a recreational drug at all. In fact, the safety label only suggests that the medication “may result in withdrawal symptoms” in the ... Read More

Estarylla birth control pills recalled due to packaging flaw

One lot of Estarylla birth control pills made by Sandoz is being recalled because a customer found an inactive tablet in a row of active tablets in one pack. The pill packs include blue tablets, or active pills, that contain a combination of the hormones norgestimate and ethinyl estradiol that work to stop ovulation and thus prevent pregnancy. The green pills, sometimes called placebos or sugar pills, contain only inactive ingredients. Sandoz is not aware of any adverse events associated with the recall. The company conducted an internal medical assessment and concluded that the likelihood of adverse health effects is ... Read More

Birth control pills recalled due to packaging flaw

Ten lots of the generic birth control pill Introvale made by Sandoz are being recalled because of a packaging flaw that if undetected could result in unintended pregnancy. The recall was initiated after a consumer reported that the white placebo tablets were mistakenly in the ninth row (labeled “Week 9”) of the 13-row blister card, rather than in the 13th and final row (labeled “Week 13”). Each three-month blister card contains 84 peach-colored active tablets and seven white placebo tablets in 13 rows, with each row representing one week. While the white placebo pills can be clearly distinguished from the ... Read More

Bayer continues to fight generic competition of its birth control pills

The Food and Drug Administration (FDA) may have granted permission to drug companies to market generic versions of Bayer’s blockbuster birth control pills Yasmin and Yaz, but Bayer is not giving up its fight to prevent other companies from taking a bite out its profits. The German drug company said Wednesday it will continue trying to protects its patents on its pills despite a New York judge’s dismissal of Bayer’s latest patent infringement lawsuit late Tuesday against Watson Pharmaceuticals and Sandoz. Yasmin and Yaz generate nearly $2 billion each year for Bayer, making the oral contraceptives the largest source of ... Read More

FDA approval for marketing generic Lovenox expected

The expiration of exclusivity period for Sanofi Aventis’ blood thinner Lovenox has expired, moving Momenta Pharmaceutical Inc. one step closer to gaining approval from the Food and Drug Administration (FDA) to manufacture and market is generic Lovenox, M-Enoxaparin, according to Momenta’s first quarter 2009 Earnings Call. Anticoagulants are often administered to patients before undergoing some surgeries and medical procedures to reduce the risk of life-threatening blood clots. Lovenox has been touted as an effective replacement for the blood thinner heparin in patients undergoing abdominal surgery. Heparin carries a laundry list of side effects such as nausea, vomiting, abdominal pain, diarrhea ... Read More