Sandoz launches generic version of Pulmicort Respules®
Princeton, New Jersey, July 28, 2015– Sandoz today announced the US market introduction of its budesonide inhalation suspension, a generic version of Pulmicort Respules® (budesonide) inhalation suspension 1 mg strength by AstraZeneca LP.
Sandoz’s budesonide inhalation suspension product is indicated for maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Budesonide inhalation suspension is not indicated for the relief of acute bronchospasm.
"Asthma is unfortunately becoming increasingly prevalent while few generic alternatives exist for the biggest and most expensive products,” said Peter Goldschmidt, President of Sandoz Inc. “As a leading US provider of affordable, high-quality medicines, we are pleased to be the first company to make high-quality generic budesonide inhalation suspension 1mg strength available.”
According to IMS Health, US sales for budesonide inhalation suspension were approximately USD 242 million for the 12 months ending in May 2015. Sandoz will market budesonide inhalation suspension in 1mg strength and expects 180-day generic drug marketing exclusivity for the 1mg strength.
Important Safety Information
See full prescribing information for additional information, available at dailymed.nlm.nih.gov:
The use of budesonide inhalation suspension is contraindicated in the following conditions: Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
Hypersensitivity to budesonide or any of the ingredients of budesonide inhalation suspension [see Warnings and Precautions (5.3),Description (11) and Adverse Reactions, Post-marketing Experience (6.2)
Budesonide inhalation suspension is not a bronchodilator and should NOT be used to treat an acute asthma attack. If your child is switching to budesonide inhalation suspension from an oral corticosteroid, follow the doctor's instructions to avoid serious health risks when your child stops using oral corticosteroids.
Only use budesonide inhalation suspension with a jet nebulizer machine that is connected to an air compressor. Do not use an ultrasonic nebulizer.
Thrush infection of the mouth and throat may occur with budesonide inhalation suspension.
Avoid exposure of your child to infections such as chicken pox and measles. Tell your doctor immediately if your child is exposed.
Inhaled corticosteroids may cause a reduction in growth rate. The long-term effect on final adult height is unknown.
Budesonide inhalation suspension should not be used if your child is allergic to budesonide or any of the ingredients.
Be sure to tell the healthcare provider about all your child's health conditions and all medicines he or she may be taking.
As with other inhaled asthma medications, bronchospasm, with an immediate increase in wheezing, may occur after dosing. If bronchospasm occurs following dosing with budesonide inhalation suspension, it should be treated immediately with a fast-acting inhaled bronchodilator. Treatment with budesonide inhalation suspension should be stopped and your physician consulted.
The most common side effects include respiratory infection, runny nose, coughing, ear infection, viral infection, thrush in the mouth and throat, inflammation of the stomach including vomiting, diarrhea, abdominal pain and loss of appetite, nose bleed, pink eye, and rash.
The foregoing release contains forward-looking statements that can be identified by words such as “launches,” “introduction,” “becoming increasingly prevalent,” “will,” “expects,” or similar terms, or by express or implied discussions regarding potential future product approvals, or regarding potential revenues from budesonide inhalation suspension. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any potential new products will receive regulatory approval in the future, or that budesonide inhalation suspension or any such potential new products will be commercially successful in the future. In particular, management’s expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; competition in general, including potential approval of additional versions of budesonide inhalation suspension for sale either before or after the end of Sandoz expected 180-day exclusivity period; government, industry and general public pricing pressures; unexpected patent litigation outcomes; unexpected manufacturing issues; general economic and industry conditions, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Sandoz, a division of Novartis, is a global leader in generic pharmaceuticals, driving sustainable access to high-quality healthcare. Sandoz employs more than 26,000 people worldwide and supplies a broad range of affordable products to patients and customers around the globe.
The Sandoz global portfolio comprises approximately 1,100 molecules, which accounted for 2014 sales of USD 9.6 billion. Sandoz holds the global #1 position in biosimilars as well as in generic anti-infectives, ophthalmics and transplantation medicines. Sandoz also holds leading global positions in key therapeutic areas ranging from generic injectables, dermatology and respiratory to cardiovascular, metabolism, central nervous system, pain and gastrointestinal.
Sandoz develops, produces and markets finished dosage form (FDF) medicines as well as intermediary products including active pharmaceutical ingredients (APIs) and biotechnological substances. Nearly half of the Sandoz portfolio is in differentiated products – medicines that are scientifically more difficult to develop and manufacture than standard generics.
In addition to strong organic growth since consolidating its generics businesses under the Sandoz brand name in 2003, Sandoz has consistently driven growth in selected geographies and differentiated product areas through a series of targeted acquisitions, including Hexal (Germany), EBEWE Pharma (Austria), and Fougera Pharmaceuticals (US).
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For further information:
Sandoz US Communications
Sandoz Global Communications
+49 8024 476 2597
1 For full safety information, please see the budesonide inhalation suspension prescribing information, available in the Product Catalog at www.us.sandoz.com.
2 Pulmicort Respules is a registered trademark of AstraZeneca AB.