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Zydus gets FDA approval for skin, heart and acid reflux generics

Zydus Cadila has received final approval from the US Food and Drug Administration (FDA) to market betamethasone dipropionate cream, 0.05%, a generic version of Diprolene® AF, and generic amlodipine and atorvastatin tablets (Caduet®). It has also received tentative FDA approval to market generic esomeprazole magnesium delayed-release capsules (Nexium®). This brings the total approvals of the Zydus group to 247, and it has so far filed over 330 abbreviated new drug applications (ANDAs) since the filing process commenced in the 2003‒2004 financial year.

FDA approves Lupin’s generic clobazam and Dr Reddy's launches follow-on sevelamer carbonate

By end of 2018, Lupin Pharmaceuticals Inc received US Food and Drug Administration (FDA) approval for its clobazam oral suspension, 2.5 mg/mL, and Dr Reddy's Laboratories Ltd (Dr Reddy) launched its sevelamer carbonate for oral suspension.

Teva receives FDA approval for Sabril and launches Elidel cream

In January 2019, Teva Pharmaceutical Industries (Teva) received US Food and Drug Administration (FDA) approval for its first generic version of Sabril (vigabatrin) and launched a generic version of Elidel (pimecrolimus) cream, 1%, in the US.

Sun Pharma gets FDA approval for ganirelix acetate and plans to acquire Japan’s Pola Pharma

Sun Pharmaceutical Industries (Sun Pharma), one of India’s largest pharmaceutical company, marks the start of 2019 with two exciting new developments.

Dr Reddy’s launches omeprazole and continues sales of generic Suboxone in the US

India-based generics manufacturer Dr Reddy’s is set to have a busy 2019 with the recent launch of generic omeprazole delayed-release tablets for the treatment of heartburn, and the lifting of a US injunction on its anti-narcotic addiction generic Suboxone (buprenorphine and naloxone).

Sandoz to launch epinephrine in early 2019 at a discount to Mylan and Teva’s generics

Sandoz, the generics division of Novartis, will launch Adamis Pharmaceuticals Corp’s EpiPen (epinephrine) generic Symjepi in early 2019. Symjepi received US Food and Drug Administration (FDA) approval of its 0.3 mg pre-filled single dose syringe in June 2017 [1], and for its lower dose version (0.15 mg) in September 2018. Epinephrine injectors are used for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise or unknown triggers. These can include reactions to insect bites or stings, foods, medications, latex or other causes.

FDA approves drug for cancers with specific biomarker

The US Food and Drug Administration (FDA) announced on 26 November 2018 that it had approved Vitrakvi (larotrectinib), a treatment for adult and paediatric patients whose cancers have a specific genetic feature (biomarker).

Glenmark gains FDA approval for MS and pneumonia generics

In November 2018, Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced the approval of generics for the treatment of multiple sclerosis (MS) and pneumonia.

Apotex having trouble with Competitive Generic Therapy exclusivity

In August 2018, the US Food and Drug Administration (FDA) approved its first drugs under the Competitive Generic Therapy (CGT) designation. The agency granted approval to several strengths of Canada-based Apotex’s potassium chloride oral solution (10% and 20%) [1]. Being the first to receive approval under the CGT designation meant that Apotex was eligible for a 180-day period of marketing exclusivity. However, the company is now having trouble with this exclusivity due to timing issues.

Generics companies winning the legal battle in the US

Litigation in the US is clearing the way for generics competitors to enter the market. The latest cases include Spring Pharmaceuticals suing Retrophin for blocking generics of kidney stone drug Thiola (tiopronin) and the invalidation of Johnson & Johnson’s (J&J) patent on its prostate cancer drug Zytiga (abiraterone acetate).